1155 search results for "diabetic foot ulcer infection"

Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection …

Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety

Summary:** In a phase 1b multi-center RCT, topical pravibismane—a broad-spectrum anti-infective targeting biofilm pathogens—was safe and well-tolerated in 53 patients with moderate-severe diabetic foot ulcer infections over 4 weeks as adjunct to standard care. It achieved ~3x greater ulcer size reduction, substantially lower amputation rates, and microbiological clearance of key bacteria vs placebo. The findings warrant further development for resistant infections in DFUs, where biofilms hinder 50% of cases.

Key Highlights:

Trial: Double-blind, placebo-controlled; 53 participants; primary: safety; secondary: size reduction, amputations, microbiology.

Safety: Well-tolerated across doses; no significant issues.

Efficacy: 3x ulcer reduction; lower amputations; effective vs biofilm-forming pathogens.

Authors: Benjamin Lipsky, David Armstrong, Kim PJ, Murphy B, McKernan PA, Baker BHJ.

Implications: Addresses AMR; potential for faster closure in infected DFUs.

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Keywords: topical pravibismane, diabetic foot infection, biofilm, amputation rates, phase 1b trial

Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates ….

Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety

Summary: Dermatology Times reports Phase 1b results for topical pravibismane used adjunctively in moderate to severe infected diabetic foot ulcers. The therapy was well-tolerated and associated with favorable healing signals alongside standard care, with the source article published in the International Wound Journal.

Key Highlights:

Adjunct topical pravibismane vs placebo in infected DFUs.

Safety and tolerability demonstrated across tested doses.

Signals toward greater ulcer-size reduction and fewer ulcer-related amputations.

Larger, confirmatory trials are warranted.

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Keywords: pravibismane, diabetic foot ulcer, International Wound Journal, Lipsky

Microbion Corporation Receives up to $2.1 million in Funding Support from the US Navy

in Partnership with CUBRC, Inc. to Advance Topical Pravibismane

Funding will support exploratory phase 2 proof-of-concept study in patients hospitalized for moderate to severe diabetic foot ulcer infection (DFI)

BOZEMAN, Mont. and VANCOUVER, BC, June 7, 2022 /PRNewswire/ – Microbion Corporation of Bozeman, MT, today announced that it has received non-dilutive funding through its strategic partnership with CUBRC, Inc., a Buffalo-based, independent not-for-profit research company, of up to $2.1 million from the US Navy through the Medical Technology Enterprise Consortium (MTEC) partnership. The funding project is titled “Pravibismane Suspension as a Topical, Broad Spectrum Anti-Infective Wound Care Treatment and Prevention for Combat Injury-Related Infections”. The funding received will be used to support the conduct of an exploratory phase 2 proof of concept trial in patients hospitalized for moderate to severe diabetic foot ulcer infection with enrollment expected to begin in Q2 2022.

“We are pleased to be supported by the US Navy and MTEC and are working closely with them to advance our topical pravibismane through phase 2 proof-of-concept studies,” said Karim Lalji, CEO of Microbion Pharma Corp. “Our topical diabetic foot ulcer infection program is well aligned to the Navy’s interest in innovative wound care technologies to treat and prevent biofilm-related infections, since biofilm contamination is a hallmark characteristic of chronic foot ulcer infections. Further exploration of pravibismane’s safety and efficacy in overcoming biofilm-related DFI may potentially expand the clinical utility of topical pravibismane to treat combat wound infections in a variety of settings, including in the field and hospital.”

Lester Martinez, MD, MPH, Major General (Retired), U.S. Army, President and Chairman of MTEC Board commented on the importance of Microbion’s research. “Though diabetic foot ulcer infections aren’t traditionally thought of as a combat related wound suffered in the field, diabetes is a serious disease that affects a significantly high percentage of our veterans and its complications such as DFI contributes to decline in health, quality of life and are responsible for the vast majority of non-combat amputations among veterans. Microbion’s research into healing these wounds with the ultimate goal of preventing or delaying amputations can potentially improve the daily lives of these patients and return normal mobility,” Dr. Martinez stated.

Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics. With a novel mechanism of action, pravibismane shuts down bacterial ATP production thereby halting global bacterial cellular metabolism. In in vitro studies, pravibismane exhibits broad-spectrum, potent activity against DFI-relevant pathogens and their biofilms including MRSA and drug resistant P. aeruginosa.

In a randomized, double-blind, placebo-controlled Phase 1b trial treating patients with chronic moderate to severe diabetic foot ulcer infection, topical pravibismane treatment plus standard of care demonstrated a numeric 85% wound size reduction versus 30% placebo plus standard of care. Pravibismane also demonstrated a numeric reduction in ulcer-related amputation (2.6% in the pravibismane group vs 15.4% placebo).

DFIs are a major health concern in the Veterans Health Administration as DFUs are associated with a substantial mortality rate (five-year mortality rates are as high as 45% for neuropathic ulcers and 55% for ischemic ulcers1) and often require amputation to fully address the nidus of infection.2 Approximately 28.5 million adults in the US are diagnosed with diabetes, of whom 15 – 25% are at risk of developing a foot ulcer.3,4 More than half of diabetic foot ulcers become infected.5 DFIs remain the most frequent diabetic complication requiring hospitalization and are the most common precipitating event leading to lower extremity amputation.6 Furthermore, recent studies suggest that many DFIs are caused by bacteria in a biofilm mode.6 In 2018, there were ~8.25 million hospital discharges with diabetes reported, including 154,000 for a lower-extremity amputation.3 US Veterans Affairs estimates there were 20.3 million living Veterans in 2018.7 The overall prevalence of diabetes among US veterans is ~25%, which is higher than the US civilian population at ~9%.8

References:

Del Core MA, Ahn J, Lewis RB, et al. The evaluation and treatment of diabetic foot ulcers and diabetic foot infections. Foot & Ankle Orthopaedics. 2018;3:3. doi:10.1177/2473011418788864

Sundararajan PP, Porter BM, Grant KA, et al. Foot infections in the Veterans Health Administration. The Foot and Ankle Online Journal. 2015;8(3):1. doi:10.3827/faoj.2015.0803.0001

Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html, accessed June 6, 2022

Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112–26. doi: 10.1111/wrr.12391

Armstrong, DG, Boulton, AJM, and Bus, SA. Diabetic foot ulcers and their recurrence. N Engl J Med. 2017;376:2367-75. doi: 10.1056/NEJMra1615439

Lipsky et al. Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diab Metab Res Rev. 2020. e3280. doi: 10.1002/dmrr.3280

VETPop2018: A Brief Description. Web: https://www.va.gov/vetdata/docs/Demographics/New_Vetpop_Model/VP_18_A_Brief_Description.pdf, accessed June 6, 2022

Liu Y, Sayam S, Shao X, et al. Prevalence of and trends in diabetes among veterans, United States, 2005–2014. Prev Chronic Dis. 2017;14:170230. doi: 10.5888/pcd14.170230

About Microbion
Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion’s lead drug candidate, pravibismane, is the first product in this new class and has a novel mechanism of action offering unique potential to address the unmet needs of chronic and severe health conditions. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane with Orphan Drug, Fast Track, and QIDP designations. Microbion Pharma Corp. is a wholly owned subsidiary of Microbion Corporation. For more information visit: www.microbioncorp.com.

About CUBRC
CUBRC is an independent not-for-profit scientific corporation that executes Research, Development, Testing and Systems Integration programs in Medical Sciences, Chemical and Biological Defense, Data Science and Information Fusion, Command and Control, and Hypersonics. For more information visit: www.cubrc.org.

Safe Harbor Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

US Government Funding Disclaimer
Efforts described herein were partially sponsored by the Government under Other Transactions Number W81XWH-15-9-0001. The U.S. Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

SOURCE Microbion Corporation

This article was originally published here

Amniotic membrane can be a valid source for wound healing

Abstract

Amniotic membrane (AM) can promote proper epithelialization with suppression of excessive fibrosis by creating a supportive milieu for regeneration of chronic ulcer bed.

Objective

The objective of this study is to investigate whether AM scaffold can modulate the healing of a wound by promoting tissue reconstruction rather than promoting scar tissue formation.

Subjects and methods

AM was obtained and prepared and then applied to patients with chronic leg ulcers who were randomly divided into two different groups. Group I (control group) included eleven patients in whom ulcers were treated with conventional wound dressings that were changed daily for 8 weeks. Group II (study group) included 14 patients in whom the AM was placed in contact with the ulcer and held in place with a secondary dressing, which was changed daily. Follow-up was done to detect healing rate and detection of ulcer size, assessment of pain, and to take ulcer images (days 0, 7, 14, 21, 30, 45, and 60).

Results

In group I, all ulcers showed no reduction in their size, and ulcer floor remained the same. Healthy granulations were present in two ulcers (18.2%) and absent in nine ulcers (81.8%). There was no improvement of pain level in the eleven ulcers. In group II, complete healing of 14 ulcers occurred in 14–60 days with a mean of 33.3±14.7; healing rate range was 0.064–2.22 and the mean 0.896±0.646 cm²/day. Healthy granulations were present in 13 ulcers (92.9%) and absent in one ulcer (7.1%). Three ulcers (21.4%) were of mild severity (grade 1 ulcers) while eleven ulcers (78.6%) were of moderate severity (grade 2 ulcers). The healing rate was faster in ulcers of mild severity (1.7±0.438 cm²/day) in comparison to ulcers of moderate severity (0.673±0.498 cm²/day). Eleven cases (78.6%) showed improvement in their pain level on a scale from 0 to 10.

Conclusion

AM graft can be of value in wound healing. Further studies are needed to confirm these findings.

Keywords: amniotic membrane, ulcer, placenta, cesarean section

Introduction

Amniotic membrane (AM) is an attractive method of grafting for wounds as it has unique properties, including anti-inflammatory effects, bacteriostatic, wound protection, decreased scarring, and pain reduction properties, as well as epithelialization initialization capacities. Furthermore, AM is widely available and less costly than other bioengineered skin substitutes. Human AM was used for 2,308 ophthalmologic reconstructions in Germany 2008. Its special success in ophthalmology may be due to the immune privileged properties of the AM.

The anti-inflammatory property of AM seems to be a result of production of anti-inflammatory proteins and reduction of expression of transforming growth factor B and pro-inflammatory cytokines, such as interleukin. Also, AM produces B defensins, elastase inhibitors, elastin, and lactoferrin that contribute to its anti-inflammatory and antimicrobial effects. The reduction in scarring after application of AM to wounds might be due to the anti-inflammatory effects, acceleration of epithelialization, and inhibition of fibrosis. Accelerated reepithelialization was also demonstrated by Maral et al after covering split thickness skin graft with AM in rats. Loeffelbein et al demonstrated accelerated formation of basement membrane in wounds treated with AM that might be due to the release of growth factors. One of the most important properties of AM as a skin substitute is pain relieving which may be due to diminished inflammation, better hydration of wound bed, and protection of exposed nerve endings. AM expresses few antigens, which accounts for its good tolerability and the absence of rejection reactions. AM expresses many neurotrophic and angiogenic factors: endothelin-2 and -3, vascular endothelial growth factor, vascular endothelial growth factor-B, Tie-2 angiopoietin receptor, ephrin-A2, ephrin receptors A2, B1, B3, B4, B5, neuropilin-2, nerve growth factor receptor, and semaphorin-F19 as well as erythropoietin and its receptor that contribute to healing of wounds. Some studies demonstrated the effectiveness of AM graft for healing of wounds. Mermet et al put an AM graft for 15 chronic leg ulcers and healing occurred in all patients. Pesteil et al used cryopreserved AM in eight patients with resistant vascular ulcers. Tolerance to the graft was excellent with healing of six out of eight patients with significant improved pain. Alsina-Gibert and Pedregosa-Fauste used AM for four refractory ulcers with a mean 81.93% reduction of ulcer size after 16 weeks. Litwiniuk et al suggested the potential role of matrix metalloproteinase inhibitors present in radiation-sterilized amnion dressing in healing of 23 out of 25 patients with chronic venous ulcers. Sheikh et al used dehydrated amnion to provoke healing of chronic wounds in four patients and healed wounds did not recur on long-term follow-up. A similar study was done by Zelen et al who used dehydrated AM in diabetic foot ulcers with complete healing of 37 out of 40 ulcers. With respect to the low cost, wide availability, and easy preparation, AM can be an ideal graft for chronic refractory ulcers.

Subjects and methods

Study design

This was an experimental, comparative, and randomized clinical trial.

Description of patients and collection of data

This study was performed to test a technique for the treatment of chronic nonhealing wounds using AM to express its effect on the rate of healing of such nonhealing ulcers. Patients were recruited from the outpatient clinics or the inpatient wards of the Department of General Surgery, Faculty of Medicine, Cairo University and Department of Vascular Surgery, Faculty of Medicine, Assiut University from June 2012 to June 2015. Each patient signed an informed consent after accepting to be enrolled in the study. Ethical aspects whether substantial or procedural have been implicated in this study and approval was obtained from the Faculty of Medicine, Ethical Committee of Cairo University (30-9-2012).

Patients were then randomly divided into two different groups. Group I (the control group) included eleven patients with eleven chronic leg ulcers in whom ulcers were treated with conventional wound dressings that were changed daily for 8 weeks. Group II (the study group) included 14 patients with 14 chronic leg ulcers. The AM was placed in contact with the ulcer and held in place with a secondary dressing, which was changed daily. Inclusion criteria were presence of leg ulcers for more than 3 months with no improvement despite standard treatment and age between 26 and 43 years. Exclusion criteria were ulcers with ongoing active infection and presence of diabetes. Full history taking and clinical assessment were done with special reference to previous treatment and surgery, diagnosed diabetes and/or hypertension, causes, types, and duration of ulcers present.

The follow-up during treatment period includes assessment of ulcer healing and pain. Ulcer healing was assessed using the percentage of the healed wound area and healing rate. Using ImageJ program (Rasband, W.S., ImageJ, US National Institutes of Health, Bethesda, Maryland, USA), the wound areas were analyzed and a percentage of the healed wound area was calculated, in respect to the original wound area and the final wound area after 2 weeks and at the end of 2 months according to the formula:

$Percentage of healed wound area = Original wound area - Final wound area Original wound area \times 100 The healing rate was then determined, in respect to the original wound area, and the final wound area reached according to the formula:$

$Healing rate = Original wound area-Final wound area Time cons uumed to reach final wound area$

The wound area is calculated by the formula for determining the area of an ellipse ((length × width) × π/4). Results of measured ulcer area size were used for follow-up, and ulcers were categorized with respect to surface area, exudate, and type of wound tissue. A comparison of total measurements over time provided an indicator of improvement or deterioration in ulcer healing. Pain was assessed using a visual analog scale, where 0 represented no pain and 10 represented the worst pain. Each patient has a special file in which all the data were present. Then, merging of data of all patients was done before statistical analysis.

AM isolation, preservation, grafting, and follow-up of patients

Human AM was prepared from placentae obtained from scheduled delivery by cesarean section following a noncomplicated pregnancy. Exclusion criteria were symptoms of infection in the newborn, delivery before 34 weeks gestation, and membrane rupture more than 12 hours before delivery. The donors gave written informed consent for the donation and use of the AM. One placenta can provide four to five AM tissue fragments 5 cm in diameter.

Preparation was performed in a classified (class D) room with a microbiological safety workstation (class A). The placenta was washed with physiological saline and left in contact with an antibiotic solution in its collection container until preparation within 2 hours of the cesarean delivery. The entire membrane structure was immersed in a sterile packing container. The AM is mixed with antibiotics and antifungal in the container. The AM was then cut into different sizes and AM tissue fragments were obtained (Figure 1). For cryopreservation of AM, a cryoprotective agent was added (Roswell Park Memorial Institute medium [RPMI] and glycerol), and then stored in a temperature of −80°C with each piece of the AM stored in a separate container. Three AM samples are collected for bacteriological examination. The placenta rinse fluid (8–10 mL) was used to inoculate two vials of aerobic and anaerobic organisms for bacteriological testing. The placenta was also prepared for a pathological evaluation. On the day of the cesarean section, test tubes containing blood from the mother were collected for the following serology tests: HIV-1 and -2, Ag p24, HCV, HTLV; syphilis: VDRL-TPHA; and HBV: HBs antigen-HBc antibody. Final validation of the AM was performed after a repeat serology test by testing again the donor woman after 120 days. Before use, the AM can be transported to hospital and stored on dry ice up to 24 hours and conserved up to 2 hours in normal saline at room temperature after thawing before utilization.

Figure 1

Preparation of amniotic membrane pieces.

The preparation of the ulcers includes cleaning and mechanical debridement with a scalpel. The membrane preservation solution was removed by washing with physiological saline and the membrane was applied directly onto the ulcer bed (Figure 2). The graft was then covered with vaseline dressing (Figure 3). Patients were confined to bed for 2 hours and then allowed to do moderate activity for the next 5 days.

Figure 2

Amniotic membrane application over two leg ulcers.

Notes: Two leg ulcers in one patient (A); application of amniotic membrane over the leg ulcers (B and C); image of the patient after amniotic membrane grafting (D).

Figure 3

Vaseline dressing is added over amniotic membrane and then covered with dressing.

Notes: Application of vaseline dressing (A and B); application of gauze dressing after vaseline (C); gauze wrapping at the end (D).

Follow-up was done to detect healing rate and detection of ulcer size, assessment of pain, and to take ulcer images (days 0, 7, 14, 21, 30, 45, and 60). Statistical analyses of all data were performed with SPSS software version 15.0 for Windows (SPSS Inc, Chicago, IL, USA). A two-sided value of P<0.05 was considered statistically significant for all analyses. Continuous variables are presented as mean ± standard deviation (SD).

Results

Demographic data of the sample

All patients were males between 26 and 43 years. In group I, there were a total of eleven leg ulcers. Age ranged from 26 to 43 years with a mean value 34.45±7.03. Nine ulcers (81.8%) were venous ulcers, while two ulcers (18.2%) were traumatic ulcers. In group II, there were a total number of 14 leg ulcers. Age ranged from 26 to 43 years with a mean value 32.86±6.94. Twelve ulcers (85.7%) were venous ulcers, while two ulcers (14.3%) were traumatic ulcers. All patients of groups I and II were nondiabetics, with no history of smoking, hypertension, or any other medical condition.

Results of the study

Only conventional treatment was performed for the control group. Chronicity of leg ulcers varied from 24 to 60 months. The ulcer area at the beginning of the study was 4.8±0.65 cm² (mean ± SD). Mean percentage of healing rate was 0%, and all ulcers in this group showed no reduction in their size (Tables 1and and 2), and ulcer floor remained the same. Healthy granulations were present in two ulcers (18.2%) and absent in nine ulcers (81.8%). There is no improvement of pain level in the eleven ulcers (Table 3).

Table 1

Chronicity of leg ulcers, reduction in ulcer size with treatment, and healing rate

Parameters of healing Group I Group II

Chronicity of leg ulcer (range) 24–60 months 24–84 months

Chronicity of leg ulcer (mean + SD) 45.82+14.01 months 50.57+16.43 months

Reduction of ulcer size with treatment 0% 100% reduction in size

Reduction of ulcer size with treatment (mean + SD) 0.0+0.0 100.0+0.0

Healing rate cm²/day (range) 0.0–0.0 0.064–2.22

Healing rate cm²/day (mean + SD) 0.0+0.0 0.896±0.646

Abbreviation: SD, standard deviation.

Table 2

Percentage of healed ulcers

Ulcer healing Group I Group II

No healing 11 100% 0 0%

Complete healing 0 0% 14 100%

Incomplete healing 0 0% 0 0%

Notes: Group I included patients without amniotic membrane application; while Group II included patients with amniotic membrane application.

Table 3

Pain level improved or remained the same from day 0 till the end of study

Pain level Group I Group II

No pain 0 0.0% 3 21.4%

Improved 0 0.0% 11 78.6%

The same 11 100% 0 0.0%

In the study group, the AM was directly applied on leg ulcers. This group included 14 leg ulcers. Chronicity of leg ulcers varied from 24 to 84 months. The ulcer area at the start of the study was 5.1±0.48 cm² (mean ± SD). Results obtained from the study group showed complete healing of 14 ulcers in 14–60 days with a mean of 33.3±14.7; healing rate range was 0.064–2.22 and mean 0.896±0.646 cm²/day with a 100% reduction in ulcer size. Ulcer floor improved in all ulcers. Healthy granulations were present in 13 ulcers (92.9%) and absent in one ulcer (7.1%). Three ulcers (21.4%) were of mild severity (grade 1 ulcers) while eleven ulcers (78.6%) were of moderate severity (grade 2 ulcers). The healing rate was faster in ulcers of mild severity (1.7±0.438 cm²/day) in comparison to ulcers of moderate severity (0.673±0.498 cm²/day). Eleven cases (78.6%) showed improvement in their pain level on a scale from 1 to 10. Three patients had no pain (Tables 11–3; Figure 4). AM graft was taken in four cases (28.6%), while AM was not taken in ten cases (71.4%) in the days following the graft application. In these ten cases, the ulcers also showed complete healing on follow-up. Reduction in ulcer size shows significant difference between group I (control group) in comparison to group II (P=0.001) in which we used AM alone.

Figure 4

Healing of two leg ulcers after amniotic membrane application.

Notes: Two leg ulcers in one patient (A); application of amniotic membrane on the two ulcers (B); reduction in size of both ulcers (C); complete healing of the upper ulcer and 70% reduction in the size of the lower one on follow up (D).

Discussion

Chronic leg ulcers are defined as a defect in the skin, below the level of the knee and above the foot, persisting for 6 weeks or more. A previous study found that ~60%–80% of chronic leg ulcers had a venous component, 10%–30% was associated with arterial insufficiency, and other factors included diabetes mellitus and rheumatoid disease. Arterial and venous insufficiency combined in 10%–20% of cases.

Chronic leg ulcers often heal poorly if there is no revascularization. Different lines of treatment are based on optimized local wound care: cleansing, debridement and dressings, compression therapy, and skin grafting. AM graft can be used as placental tissues contain a large quantity of growth factors. Furthermore, AM downregulates transforming growth factor (TGF)-β and its receptor expression by fibroblasts and in doing so it reduces the risk of fibrosis. Therefore, an AM scaffold can modulate the healing of a wound by promoting tissue reconstruction rather than promoting scar tissue formation.

AM is a natural scaffold, which is the supporting matrix upon which cells and tissues grow, and so it is considered an important component of tissue repair with multiple clinical applications. In addition, the AM has other biological properties important for tissue repair, including anti-inflammatory, antimicrobial, antifibrosis, antiscarring, and low immunogenicity as previously discussed. AM may thus be regarded as a bio-therapeutic product composed of a single layer of epithelial cells that lie on a basement membrane and of a nonvascular collagenous stroma. These three components give AM its beneficial properties, including antiadhesive effects, bacteriostatic properties, wound protection, pain reduction, and epithelialization effects.

The AM epithelial cells reside on the inner layer of the AM, while amniotic mesenchymal stromal cells form the outer layer.

Results obtained from our study group showed complete healing of 14 ulcers in 14–60 days with a mean of 33.3±14.7; healing rate range was 0.064–2.22 and mean 0.896±0.646 cm²/day with a 100% reduction in ulcer size. Ulcer floor improved in all ulcers. Healthy granulations were present in 13 ulcers (92.9%) and absent in one ulcer (7.1%). Three ulcers (21.4%) were of mild severity (grade 1 ulcers) while eleven ulcers (78.6%) were of moderate severity (grade 2 ulcers). Eleven cases (78.6%) showed improvement in their pain level on a scale from 1 to 10. AM graft was taken in four cases (28.6%), while AM was not taken in ten cases (71.4%).

The current study results were supported by the results of Mermet et al in a prospective pilot study, in which they evaluated the safety, feasibility, and the effects on healing of AM graft in 15 patients with chronic venous leg ulcers. The percentage of granulation tissue increased significantly (from 17% on day 0 to 69% on day 14, P<0.0001), along with a significant decrease of fibrinous slough (from 36% at day 0 to 16% at day 14, P<0.001). There was significant reduction in ulcer size and pain level as well. Also, Alsina-Gibert and Pedregosa-Fauste performed AM transplantation for four refractory vascular ulcers. Complete wound reepithelialization was achieved for one ulcer by week 8; in the other three cases, there was a 50% reduction in size compared to baseline. At week 16, the mean reduction in wound size for the four ulcers was 81.93%. The corresponding reduction in pain intensity was 86.6%. No adverse effects were observed.

To our knowledge, this is the first study to prove the possible efficacy of AM in treating nonvascular (traumatic) refractory wounds (two cases in this study) in addition to efficacy in treating vascular refractory ulcers (12 cases in this study) that was shown by previous similar studies. The limitation of this study is the small number that needs further studies to support it.

Conclusion

AM graft can be an ideal choice instead of tissue-engineered skin equivalents to be used in wound healing. In addition to being an excellent scaffold, it has unique biological properties that are important for tissue repair, including anti-inflammatory, antimicrobial, antifibrosis, antiscarring, as well as a reasonable cost and low immunogenicity. Furthermore, presence of its own progenitor cells help in tissue repair.

Recommendations and implications to practice

Further studies should be done to support this study results. Comparing AM with alternative allogeneic or autologous skin substitutes in a randomized study will be worthwhile to determine the best therapeutic option and establish the potential of using AM in the treatment of leg ulcers. Routine preparation and preservation of AM will be of great value in tissue repair programs and implementation of biotherapy especially in developing countries due to its efficacy and low cost.

Footnotes

Disclosure

The authors report no conflicts of interest in this work.

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17. Litwiniuk M, Bikowska B, Niderla-Bielińska J, et al. Potential role of metalloproteinase inhibitors from radiation sterilized amnion dressings in the healing of venous leg ulcers. Mol Med Rep. 2012;6(4):723–728. [PubMed]

18. Sheikh E, Sheikh E, Fetterolf D. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. Int Wound J. 2014;11(6):711–717. [PubMed]

19. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated humanamnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014;11(2):122–128. [PMC free article] [PubMed]

20. Stacey M, Burnand K, Layer G, Pattison M, Browse NL. Measurement of the healing of venous ulcers. Aust N Z J Surg. 1991;61(11):844–848. [PubMed]

21. Nelzén O, Bergqvist D, Lindhagen A. Leg ulcer etiology – a cross sectional population study. J Vasc Surg. 1991;14(4):557–564. [PubMed]

22. Azuara-Blanco A, Pillai CT, Dua HS. Amniotic membrane transplantation for ocular surface reconstruction. Br J Ophthalmol. 1999;83:399–402. [PMC free article] [PubMed]

23. Gomes J, Romano A, Santos M, Dua H. Amniotic membrane use in ophthalmology. Curr Opin Ophthalmol. 2005;16:233–240. [PubMed]

24. Alio JL, Abad M, Scorsetti DH. Preparation, indications and results of human amniotic member transplantation for ocular surface disorders. Expert Rev Med Devices. 2005;2:153–160. [PubMed]

25. Mamede A, Carvalho M, Abrantes A, Laranjo M, Maia C, Bothelho M. Amniotic membrane; from structure and functions to clinical applications. Cell Tissue Res. 2012;349:2447–458. [PubMed]

Articles from International Journal of Women’s Health are provided courtesy of Dove Press

Microbion Corp. Presents a Poster on Pravibismane’s Activity Against Diabetic Foot Infection Patient Isolates

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Posted on May 18, 2023 at 1:43 pm

Poster highlights pravibismane’s MIC activity in testing against aerobic and anaerobic pathogens isolated from diabetic foot infection patients

Pravibismane demonstrated potent, broad-spectrum activity against a wide range
of pathogens, including MRSA, MSSA, and P. aeruginosa

BOZEMAN, Mont., May 10, 2023 /PRNewswire/ – Microbion Corporation today announced that the company presented a poster focusing on pravibismane’s activity against diabetic foot ulcer infection pathogens at the 9th International Symposium on the Diabetic Foot that is currently ongoing from May 10th to 13th, 2023 at The Hague, Netherlands. The poster highlights pravibismane’s activity versus comparator antibiotics against pathogens isolated from diabetic foot infection (DFI) patients in an earlier Phase 1b clinical study.

Poster Details:

Representative image (CNW Group/Microbion Corporation)

Title: Broad-Spectrum, Potent Activity of Pravibismane Versus Comparators Against Diabetic Foot Ulcer Infection Patient Isolates Collected in a Phase 1b Study

Presenter: Dr. Jeff Millard, CSO

Poster Highlights:

Most common pathogens isolated from DFI subjects (N = 44) at baseline were: methicillin-susceptible Staphylococcus aureus [MSSA (25%)]; methicillin-resistant Staphylococcus aureus [MRSA (18.2%)]; Enterococcus faecalis (13.6%); and Pseudomonas aeruginosa (11.4%).

Mean pravibismane minimum inhibitory concentration (MIC) (µg/mL) for S. aureus MSSA was 0.21, S. aureus MRSA was 0.17, E. faecalis was 2.53, and P. aeruginosa was 1.43.

Mean pravibismane MICs for 12 of the 13 anaerobic bacteria was ≤1 µg/mL, including against Finegoldia magna and Anaerococcus spp.

Pravibismane exhibited similar or lower MIC relative to a panel of comparator antibiotics, including (but not limited to) levofloxacin, linezolid, clindamycin, and piperacillin-tazobactam, against Gram-positive and Gram-negative, susceptible and resistant, aerobes and anaerobes.

"We are pleased that pravibismane demonstrated extremely potent MIC activity against clinical DFI isolates, which was in line with in vitro AST microbial pre-clinical studies," said Dr. Jeff Millard, CSO of Microbion Corp. "Diabetic foot infections are often infected by several different bacterial species concurrently, which may change over the chronicity of the wound, from predominantly aerobic to anaerobic. We believe pravibismane’s potent broad-spectrum activity is potentially a key treatment advantage since a single agent could eradicate both aerobic and anaerobic bacteria, thereby decreasing the need for multiple systemic therapies."

Bacterial cultures for this study were grown from swabs collected at the wound bed at baseline visit and antimicrobial susceptibility testing (AST) was performed on isolated pathogens. Pathogen isolation and AST was performed at Investigational Health Management Associates (IHMA, IL), using the Clinical & Laboratory Standards Institute (CLSI) standard methods.

Topical pravibismane has received QIDP and Fast Track drug designation from the US FDA for the adjunctive treatment of moderate and severe diabetic foot ulcer infections. Topical pravbismane is currently enrolling in a Phase 2 clinical study to further evaluate its safety and efficacy in subjects suffering from moderate infections associated with chronic diabetic foot ulcers.

About Microbion

Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion’s lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action offering unique potential to address the unmet needs of chronic and severe health conditions. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane with Orphan Drug, Fast Track, and QIDP designations.

For more information visit: www.microbioncorp.com.

Safe Harbor Statement

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Microbion Corporation

Topical Pravibismane Shows Promise for Diabetic Foot Infections

Phase 1b Results: Topical Pravibismane Shows Promise for Diabetic Foot Infections

Summary: This phase 1b randomized, multi-center, double-blind, placebo-controlled trial assessed topical pravibismane—a novel broad-spectrum anti-infective targeting biofilm-associated pathogens—as an adjunct to standard care for moderate to severe diabetic foot ulcer (DFU) infections in 53 patients over 4 weeks. Primarily evaluating safety, the study also captured efficacy signals, revealing nearly 3-fold greater wound size reduction, lower amputation rates, and microbiological clearance of key pathogens compared to placebo. Well-tolerated across doses with no significant safety issues, pravibismane addresses antimicrobial resistance and biofilm challenges, potentially reducing reliance on systemic antibiotics and supporting faster wound closure in this high-risk population.

Key Highlights:

Trial design: Double-blind, placebo-controlled; topical application over 4 weeks; primary endpoint safety/tolerability; secondary: wound reduction, amputations, microbiology.

Efficacy: ~3x greater ulcer size reduction vs. placebo; reduced lower extremity amputations; effective against biofilm-forming bacteria in DFUs.

Safety: Well-tolerated with no significant concerns; supports advancement to larger trials.

Expert quote (Benjamin Lipsky, MD): “We are pleased with the safety results and signals of clinical efficacy, which we believe warrant further clinical development… There is currently a major unmet need for new, easy-to-apply drug agents with multiple modes of activity to treat infection.”

Expert quote (David Armstrong, DPM, PhD): “We are encouraged by the clinical efficacy signals… We need new agents that promote faster closing of infected wounds because we are currently dependent on an expensive, time-consuming, two-pronged approach.”

Future: Sponsored by Microbion; data published in International Wound Journal (April 3, 2024); plans for further development in DFI treatment.

Read full article

Keywords: topical pravibismane, diabetic foot ulcer infection, biofilm targeting, wound size reduction, amputation prevention, Benjamin Lipsky, David Armstrong, Microbion

Chronic Inhibitory Bacterial Load (CIBL): New Clinical Terminology for Elevated Levels of Bacteria in Wounds that Preclude Healing

Findings from a New Clinical Study Using MolecuLight Imaging of Diabetic Foot Ulcers Prompts New Diagnostic Terminology Enabling Proactive Infection Management

TORONTO, Feb. 14, 2023 /PRNewswire/ – MolecuLight Inc., the leader in point-of-care fluorescence imaging that locates and detects elevated bacterial loads in and around wounds, announced the publication of “Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers“1 in International Wound Journal. The publication reports on the analysis of 138 diabetic foot ulcer wounds, highlighting the frequent presence of healing delays and elevated bacterial burden as identified through standard clinical assessment, fluorescence imaging (MolecuLight i:X®), and quantitative microbiology.

Chronic inhibitory bacterial load (“CIBL”) on the bacterial-infection continuum. Based on the International Wound Infection Institute (IWII) 2022 wound infection continuum (CNW Group/MolecuLight)

The emergence of data on the link between bacterial load and healing over the last decade, together with this current study, prompted study authors David G. Armstrong, Michael E. Edmonds, and Thomas E. Serena to define new clinical terminology, chronic inhibitory bacterial load (CIBL). CIBL is defined as “the chronic presence of bacterial microorganisms in a wound or its surrounding tissue at loads which can damage tissues and be inhibitory to healing, as well as require clinical intervention, with or without the presence of clinical symptoms”.

MolecuLight fluorescence imaging is currently the only way to detect and locate CIBL at the point of care. This term enables the proactive diagnosis of CIBL early along the bacterial-infection continuum, to facilitate its targeted removal, promote healing, and prevent the sequelae of infection in frequently asymptomatic diabetic ulcers.

Key findings of the study include:

Less than 12% of diabetic ulcers exhibited clinical symptoms of bacteria and infection, despite the presence of loads >10⁴ CFU/g in over 90% (average bacterial load of 10⁸ CFU/g). Even as bacterial loads increased up to >10⁸ CFU/g, detection of clinical signs and symptoms of infection did not increase.

Bacterial loads >10⁴ CFU/g can preclude wounds from healing through various biological mechanisms and are contraindicated for many advanced therapies. This study showed that the occurrence of delayed healing increased alongside bacterial load.

Fluorescence imaging using MolecuLight increased sensitivity for the detection of CIBL across loads 10⁴–10⁹ (p < .0001), peaking at 92.6% for bacterial loads >10⁸CFU/g. This was 8.3 times superior to standard clinical assessment alone.

Fluorescence imaging further showed that 84.2% of ulcers contained high loads in the periwound region, an area that is frequently overlooked.

Infection prevention is a key goal of CIBL’s introduction, adoption, and management. CIBL is the result of these seasoned wound care clinicians’ long-time advocacy for proactive wound management as they see firsthand the devastating consequences of delayed treatment. “Infection is the greatest destroyer of the diabetic foot. It is the final common pathway for most amputations, and we need to fight it as early as possible in its natural history”, says Dr. Michael E. Edmonds, one of the paper’s authors and Consultant of Diabetologist at the Diabetic Foot Clinic, King’s College Hospital Foundation Trust in London, UK. “CIBL localization and proactive management is a crucial strategy in reducing unnecessary amputations and saving lives”, he concludes.

As MolecuLight is the only device capable of detecting elevated bacterial loads in wounds in real-time, regions of CIBL can be non-invasively and accurately detected and mapped. The device provides clinicians with immediate feedback to guide their therapeutic decision-making process in a number of clinical settings from the outpatient clinic to the operating room. Multiple routine procedures are enhanced by its proven capabilities, such as debridement, wound hygiene, and preparation for advanced therapies resulting not only in better outcomes,3,4 but more rational resource consumption and antimicrobial stewardship.4

“There is also a meaningful role for fluorescence imaging with MolecuLight in antimicrobial stewardship. This is critical considering that approximately 70% of patients with diabetic foot ulcers are prescribed antibiotics at some point during their care, and over 80% are prescribed antimicrobial dressings3, often in a haphazard manner”, says Dr. Thomas Serena, study author and the Founder and Medical Director of The SerenaGroup®. “Diagnostic uncertainty has been listed as a key factor in antibiotic overuse in wound care. Fluorescence signals as a real-time imaging biomarker of CIBL could enable clinicians to more effectively leverage hygiene-based strategies to remove bacteria rather than resorting to antibiotics”.

“The definition of an infection’s genesis and its resolution is a clinical one”, notes Dr. David G. Armstrong, study author, Professor of Surgery at the University of Southern California, and founder and co-Director of the Southwestern Academic Limb Salvage Alliance (SALSA). “The problem is that many objective local signs may be blunted in the chronic wound and it is likely that we are not yet effectively measuring what we manage. Fluorescence imaging of chronic inhibitory bacterial load (CIBL) is positioned to potentially change contemporary paradigms of wound management. We are hopeful that this new clinical term, CIBL, can be a key indicator to enable pre-infection intervention such as debridement or modification of wound therapy.”

The MolecuLight i:X and DX are the only imaging devices for the real-time detection of elevated bacterial burden in wounds that are FDA cleared and CE and Health Canada approved. With clinical evidence including over 65 peer-reviewed publications involving 1,500 patients, they are used by leading wound care facilities globally.

References
1 Armstrong DG, Edmonds ME, Serena TE. Point-of-care fluorescence imaging reveals extent of bacterial load in diabetic foot ulcers. Int Wound J. 2023;20(2):554-566
2 Wounds International (2022) International Consensus Update 2022 International Wound Infection Institute (IWII) Wound Infection in Clinical Practice: Principles of best practice. Available from https://woundinfection-institute.com/
3 Price N. Routine fluorescence imaging to detect wound bacteria reduces antibiotic use and antimicrobial dressing expenditure while improving healing rates: retrospective analysis of 229 foot ulcers. Diagnostics (Basel). 2020;10(11):927.
4 Rahma S, Woods J, Nixon JE, Brown S, Russell DA. The use of point-of-care bacterial autofluorescence imaging in the Management of Diabetic Foot Ulcers: a pilot randomised controlled trial. Diabetes Care. 2022;45:1601-1609.

About MolecuLight Inc.
MolecuLight Inc. is a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight ‘s suite of commercial devices, which include the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, are point-of-care handheld imaging devices for the real-time detection and localization of bacterial load in wounds and digital wound measurement. MolecuLight procedures performed in the United States benefit from an available reimbursement pathway which includes two CPT® codes for physician work to perform “fluorescence imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. The company is also commercializing its unique fluorescence imaging platform technology for other global markets with relevant unmet needs in food safety, consumer cosmetics and other key industrial markets.

SOURCE MolecuLight

Clinical applications of machine learning for infection assessment in diabetic foot ulcers

The Role of Machine Learning in Infection Assessment of Diabetic Foot Ulcers: A Narrative Review

Summary: This 2026 narrative review critically evaluates machine learning (ML) applications for detecting infection in diabetic foot ulcers (DFUs), a major cause of hospitalization, amputation, and mortality in diabetes. Clinical assessment relies on subjective visual signs (redness, swelling, purulence), but inter-observer variability, atypical responses in neuropathy/ischemia, and poor documentation lead to delays or misdiagnosis. ML, especially deep learning on wound images, detects subtle infection features (erythema, exudate, necrosis, discoloration) with high accuracy. Covers image-based classification (infected vs. uninfected), tissue segmentation (necrotic vs. granulation), longitudinal monitoring, and prognostic models for healing/amputation risk. Highlights utility in telemedicine, remote monitoring, and resource-limited settings. Limitations: Image variability, dataset bias, lack of standardized protocols, limited prospective validation. Encourages ML as a supportive tool to complement clinical expertise, not replace it; calls for large-scale studies, regulatory approval, and workflow integration to reduce diagnostic errors and enable earlier intervention in DFIs.

Key Highlights:

ML excels at image-based infection detection and classification (e.g., >90% accuracy in some models)

Supports segmentation, monitoring, and prognosis in DFUs

Benefits telemedicine and resource-limited care

Limitations: Bias, variability, need for validation

Relevance: Reduces subjectivity in chronic diabetic wound infection assessment

Read full article (open access)

Keywords: machine learning DFU, infection assessment, diabetic foot ulcer, telemedicine wound

Microbion Corporation Announces Granting of a US Patent for the Use of Topical Pravibismane

for Diabetic Foot Ulcer Infections
Microbion Corporation today announced that the US Patent and Trademark Office (USPTO) issued United States Patent No. 11,207,288 to Microbion on December 28, 2021, with claims to the use of Microbion’s proprietary pravibismane topical composition for diabetic foot infections (“DFI”). The patent, entitled “Bismuth-thiol compositions and methods for treating wounds,” extends topical pravibismane patent protection through to mid-2039. The granted claims cover the administration and use of topical pravibismane compositions in diabetic foot ulcer infections. This patent further expands Microbion’s patent portfolio, comprising granted claims to its pravibismane composition and methods of treating wounds and diabetic foot ulcers.

“We are pleased that the USPTO has granted this new patent supporting our pravibismane program for the treatment of diabetic foot infections,” said Dr. Brett Baker, Microbion’s President and Chief Innovation Officer. “This patent includes claims built on data from our Phase 1b clinical studies in infected patients. In these studies, topical pravibismane demonstrated a 3-fold reduction in chronic wound size compared to placebo when administered as an adjunct to standard of care treatment in patients with moderate to severe DFI. We are committed to developing novel therapies that fulfill the unmet needs caused by diabetic foot ulcer infections and faced by these patients every day.” … read more

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Phase 2 Triumph: PDA-002 Cell Therapy for Diabetic Foot Ulcers with PAD

Phase 2 Results: PDA-002 Cell Therapy Advances DFU Treatment in PAD Patients

Full Press Release:

Celularity Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results Demonstrating the Safety and Efficacy of Human Placenta-Derived Cells (PDA-002) for Diabetic Foot Ulcers Complicated by Peripheral Artery Disease

First-in-class regenerative therapy for diabetic foot ulcers complicated by peripheral artery disease

Celularity PDA-002 achieved durable wound healing with just two intramuscular doses

As a qualified stem cell therapy under Florida statute (§ 458.3245), effective July 1, 2025 authorizing use in wound care, orthopedics, and pain management, PDA-002 may offer licensed Florida physicians an important new tool in treating DFU patients.

FLORHAM PARK, N.J., Oct. 14, 2025 (GLOBE NEWSWIRE) — Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today announced the publication of its Phase 2 study titled “Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial,” in the International Wound Journal. Results of this study demonstrated safety and efficacy in a complex type of serious wounds in the setting of diabetes and peripheral vascular disease. Celularity’s Chairman and CEO, Robert J. Hariri, M.D., Ph.D., also commented on PDA-002 as a stem cell therapy which qualifies under a recently enacted Florida law expanding access in the state to stem cell therapies not yet approved by the U.S. Food and Drug Administration.

Approximately two million individuals in the United States are affected each year by diabetic foot ulcers (DFU), nearly half of whom have coexisting peripheral artery disease (PAD). DFU complicated by PAD represents one of the most difficult and costly challenges in wound care. Currently, there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for DFU with PAD. The estimated annual economic burden of treating DFU alone exceeds $9 billion in the United States. The presence of PAD significantly compromises lower-extremity perfusion, leading to chronic tissue ischemia, impaired angiogenesis, and delayed wound repair. PAD-associated DFUs are further characterized by persistent inflammation, altered immune response, and diminished responsiveness to standard wound care interventions. Despite five FDA-approved DFU therapies, none are currently approved for DFU complicated by PAD, underscoring the need for novel regenerative approaches that restore tissue perfusion and accelerate wound closure.

The published study included 159 adult patients with chronic diabetic foot ulcers (both with and without PAD) and was conducted across 35 clinical sites in the United States. Participants received two intramuscular doses of either PDA-002, a placenta-derived cell therapy developed by Celularity, at one of three dosage levels (3 × 10⁶, 10 × 10⁶, or 30 × 10⁶ cells), or a placebo. The primary efficacy endpoint was the number of patients who achieved complete wound closure within three months with healing that remained intact for at least four additional weeks—a more rigorous measure of durability than the standard FDA definition, which requires only two weeks of durable healing.

In patients with PAD, the highest rates of wound closure were observed with the lowest PDA-002 dose (3 × 10⁶ cells), where 38.5% of ulcers completely healed versus 22.6% in the placebo group. The data also showed faster and more sustained healing in treated patients along with fewer cases of new gangrene and foot infections compared to those who received a placebo. Across all groups, PDA-002 was well tolerated, with no serious side effects linked to the treatment. This favorable safety profile remained consistent through two years of follow-up.

The study’s findings highlight the regenerative and angiogenic potential of PDA-002 in promoting durable ulcer closure in patients with DFUs complicated by PAD, using only two doses and no retreatment.

” The publication of our PDA-002 Phase 2 results in the International Wound Journal is a significant milestone for Celularity, and importantly, for patients battling diabetic foot ulcers complicated by peripheral artery disease, which is a patient population with a critical unmet medical need and limited treatment options,” said Robert J. Hariri, M.D., Ph.D., Celularity’s Chairman and CEO. “Our data show that our investigational therapy, PDA-002, a placenta-derived, mesenchymal stromal-like cell therapy, can drive meaningful wound closure rates, reduce serious complications, and do so with a favorable safety profile. We believe PDA-002 has potential to transform the future of ischemic wound care, and these findings position us for a confirmatory Phase 3 trial aimed at delivering the first FDA-approved targeted therapy in regenerative wound care for DFU/PAD patients with this urgent and unmet need. We also believe these clinical results support additional development in clinical indications where underlying microvascular disease is a contributing factor.”

Commenting on recent developments, Dr. Hariri said, “Celularity is actively assessing opportunities to apply these findings in jurisdictions such as Florida, where PDA-002 qualifies as a stem cell therapy under a new law authorizing use by Florida physicians in wound care, orthopedics, and pain management.” Diabetes afflicts an estimated 2.1 million Floridians according to a January 2025 Florida Diabetes Advisory Council report, which found that the percentage of adult Floridians diagnosed with diabetes grew by almost half since 2002 and is now above the national average (12.2% versus 11.6%). That percentage jumps to 25.4% among Floridians ages 65 and older, or some 1.25 million people, a fifth to a third of whom will go on to develop a DFU, for which the 5-year recurrence rate is 65%. “By unleashing promising stem cell therapies like PDA-002, Florida has given physicians a potentially important new tool for the treatment of diabetic foot ulcers, a serious condition that afflicts over a quarter of a million Floridians ages 65 and older,” said Dr. Hariri.

About PDA-002

PDA-002 is a mesenchymal stromal-like cell therapy product derived from the postpartum placenta. These cells possess potent angiogenic, immunomodulatory, and tissue-repair properties, offering a novel approach to wound healing in patients for whom current therapies are inadequate.

About Celularity Inc.

Celularity Inc. (Nasdaq: CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies targeting fundamental aging mechanisms, such as cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com.

Forward Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products, including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances, or otherwise, except as otherwise required by law.

Carlos Ramirez

Senior Vice President, Celularity Inc.

Carlos.ramirez@celularity.com

(908) 845-4181

Key Highlights:

Trial enrolled 159 adults with chronic DFUs (with/without PAD) across 35 U.S. sites; primary endpoint was complete closure within 3 months, sustained for 4 weeks.

In PAD patients, low-dose PDA-002 achieved 38.5% healing vs. 22.6% placebo, with quicker onset and durability, requiring no retreatment.

Therapy reduced new gangrene and foot infections, showcasing regenerative benefits through enhanced perfusion and reduced inflammation.

Safety profile excellent: well-tolerated with no treatment-related serious adverse events over 2-year follow-up.

Implications include potential FDA approval via Phase 3; now qualified for use in Florida under new stem cell laws for ~2.1M diabetic residents.

Read full article

Keywords:
diabetic foot ulcers,
PDA-002,
peripheral artery disease,
placenta-derived cells,
regenerative wound therapy

Risks and Diagnosis of Diabetic Foot Infections

Wound care clinicians deal with foot infections all the time, but when the patient is also diabetic, an infection can progress rapidly to a critical state. In fact, it is estimated that around 56% of diabetic foot ulcers become infected, and an infected foot wound precedes about two-thirds of amputations. Being able to treat diabetic foot infections promptly – before they progress too far – helps prevent amputations, which is why your role is so crucial to a patient’s well-being.

What are the risk factors?

If you are treating a diabetic patient with a foot infection, there are a number of risk factors to consider. These include:

30-day-old wounds

Wounds that go down to the bone

Recurrent foot infections

Peripheral vascular disease

An etiology from trauma

In particular, be on high alert with your diabetic patients for what they call an occult (hidden) infection … read more

Edixomed: Breakthrough Wound Care Technology

With Potential to Strike Back Against the Threat of Killer Superbugs

A simple patch which cleverly harnesses part of the body’s own natural repair system – nitric oxide – could help in the fight against killer superbugs and antibiotic resistance according to recently published studies.

Millions of people are at risk of dying from infections every day, many of which can no longer be treated by even the strongest antibiotics.

Now, in two recently published studies, a breakthrough wound care system, created by the UK firm Edixomed, has been shown to kill a range of antibiotic-resistant bacteria including MRSA and E. Coli, both of which have the potential to be fatal for many people.

The discovery could pave the way for these easy-to-use patches to be available in hospitals across the NHS to dress wounds to prevent the growth of bacteria, and tackle established infections.

“Bacterial infections resistant to all currently available antibiotics are expected to kill over 10 million people a year by 2050. The threat is very real and of international concern; but with this technology, we have a novel, viable and innovative solution with which to strike back. Wound care is just the first of many potential applications,” said Professor Art Tucker, St Bartholomew’s Hospital, London. He added, “Importantly, nitric oxide acts against multiple targets in bacteria to kill them, hence there is a very unlikely chance of bacteria developing resistance any time in the future.”

In addition, Edixomed’s breakthrough, the EDX110 wound care system, is able to deliver nitric oxide in a sustained way to give the wound or ulcer the best chance of healing. As part of the natural healing process the body normally produces nitric oxide and uses it to signal for increased blood flow and to fight infection. Edixomed’s technology effectively “supercharges” the body’s own natural healing processes.

In fact, recently published clinical research in diabetic foot ulcers, including infected ulcers, showed that the EDX110 patch achieved the same healing in 4 weeks as the standard-of-care approaches currently used in UK hospitals achieved at 12 weeks. The standard-of-care patients were also significantly more likely to be hospitalised due to complications with their foot ulcer.

“Diabetic foot ulcers are notoriously hard-to-heal and are the leading cause of diabetes-related amputations in the UK. The recently published findings provide an essential step forward in developing solutions for the effective management of these chronic wounds,” said Professor Michael Edmonds, Principal Investigator of the pivotal diabetic foot ulcer study, King’s College Hospital, London. He added, “Reducing infection and accelerating healing could significantly contribute to a reduction in the number of avoidable amputations. EDX110 represents a major step forward in best practice care.”

In severe cases, infection of a foot ulcer in a patient with diabetes can result in lower limb amputation or worse e.g. complications such as sepsis, multi-organ failure and death.

Facts:

The NHS carries out more than 7,300 amputations each year in the UK as a result of diabetes, 80% of these are due to foot ulcers.^[4] The resulting drain on healthcare resources is enormous, with an annual cost of £1 billion to NHS England alone.^[5]

At least 700,000 people die globally from drug-resistant infections every year – 5,000 of them in the UK.^[6]^,^[7]

There have been no new classes of antibiotics approved since the 1980s and the Chief Medical Officer, Professor Dame Sally Davies warned in 2017 that resistance to antibiotics “poses a catastrophic threat”.^[8]

Key findings of the two recent studies investigating EDX110, a revolutionary new wound care system:

Laboratory tests have shown that EDX110 can kill all viable organisms for several deadly antibiotic-resistant infections including MRSA, Pseudomonas and E. Coli.^[³^]

Laboratory tests have shown that EDX110 effectively prevented and treated multi-drug resistant bacteria biofilms. Biofilms are colonies of bacteria that protect themselves from the body’s immune system and actions of antibiotics.^[³^]

EDX110 completely healed more ulcers compared with standard-of-care (ulcers completely healed: 49% vs. 30%).^[²^]

EDX110 reduced diabetic foot ulcer size by almost double the amount of standard-of-care (median percentage area reduction: 89% vs. 47%).^[²^]

About Edixomed

Edixomed is a biopharmaceutical company commercialising next generation and clinically-proven technologies from its nitric oxide platform. Using its patented scientific approach, the company’s technologies have the potential to tackle major global health challenges in wound care, dermatology and infection control. The core technology’s unique feature is its ability to replenish or supplement the body’s own supply of nitric oxide that is critical for sustaining healthy skin and organs. Nitric oxide is depleted or absent in many diseases and thus, the body’s normal healing and regenerative processes are damaged. Restoring that essential element is at the heart of Edixomed’s approach to innovative healthcare.

About EDX110

EDX110 is a revolutionary, easy-to-use, two-part wound care system, driven by Edixomed’s core sustained-release nitric oxide delivery technology. EDX110 provides a protective and cushioning layer that uniquely absorbs fluid while providing a moist environment and generating nitric oxide. The role of nitric oxide in ulcer healing involves three recognised elements: vascular, as nitric oxide influences the widening of blood vessels (vasodilation) and stimulates the growth of new blood vessels (angiogenesis);^[9]^,^[10] inflammatory, as nitric oxide influences the body’s immune response;^[11] and antimicrobial, as nitric oxide demonstrates potent, broad spectrum antimicrobial activity.

EDX110 is not yet an approved product, Edixomed are pursuing an active programme to develop applications of their core technology in multiple wound care indications and a number of additional areas. These areas include: surgical wound care, venous leg ulcers, pressure ulcers, burns, septic shock, transdermal drug delivery, ventilator-associated pneumonia, cystic fibrosis, and various applications connected to antimicrobial resistance.

About nitric oxide

The discovery that a simple gas, nitric oxide, could play such an important role in the human body led to three scientists being awarded the Nobel Prize for medicine in 1998. The pioneering work demonstrated that the normal function of nitric oxide is to control blood flow in the small vessels in the skin and prevent the skin from being infected with dangerous organisms. Nitric oxide is also generated whenever the skin is injured or damaged and plays a crucial part in the normal skin healing process. However, in certain conditions, such as diabetes, the normal production of nitric oxide can be put at risk and the skin loses the essential ingredient it needs to repair itself. The result is a chronic, poorly healing wound, highly prone to infection and a major cause of concern to patients and doctors. Replenishing the missing nitric oxide in such a way as to mimic the skin’s natural production is no easy task and it has eluded many of the world’s leading scientists for the past two decades. Edixomed has succeeded in achieving this goal and has demonstrated the performance of its technology in a pivotal clinical trial.

You can also visit our website at: http://www.edixomed.com

Press Release from PR Newswire

Boruta Algorithm–Guided Antibiotic Selection in Antibiotic-Loaded Bone Cement for Diabetic Foot Ulcers

Boruta Algorithm–Guided Antibiotic Selection in Antibiotic-Loaded Bone Cement for Diabetic Foot Ulcers: Microbiota and Susceptibility Analysis

Summary: A new study explores how machine learning can improve antibiotic choices in treating diabetic foot ulcer infections (DFIs) with antibiotic-loaded bone cement. By analyzing wound microbiota and using the Boruta algorithm, researchers identified antibiotics most effective against common pathogens and highlighted the role of patient age in guiding therapy.

Key Highlights:

Study approach: Exudates from DFI wounds were cultured for bacterial identification and antibiotic susceptibility testing. The Boruta algorithm was applied to evaluate antibiotic effectiveness.

Microbiota profile: Gram-positive organisms dominated, with Staphylococcus aureus frequently isolated.

Antibiotic options: Gentamicin and tobramycin emerged as effective for gram-negative bacteria, while moxifloxacin, ampicillin, and quinupristin-dalfopristin showed strong performance against gram-positive isolates.

Influence of age: Patient age significantly affected cumulative bacterial sensitivity, suggesting the need for age-aware antibiotic protocols.

Clinical implications: Tailoring antibiotic selection to both pathogen profiles and patient demographics may improve DFI outcomes and reduce resistance risks.

Read the full article in Frontiers in Pharmacology

Keywords:
diabetic foot ulcer,
antibiotic-loaded bone cement,
Boruta algorithm,
bacterial microbiota,
antibiotic susceptibility,
wound infection management

Mechanisms of microbial infection and wound healing in diabetic foot ulcer

Mechanisms of microbial infection and wound healing in diabetic foot ulcer: pathogenicity in the inflammatory-proliferative phase, chronicity, and treatment strategies

Summary: This narrative review examines how microbial infection disrupts the healing phases of diabetic foot ulcers (DFUs), particularly from inflammation to proliferation, and explores treatment strategies. The authors integrate microbial pathogenesis (e.g. virulence, biofilms, polymicrobial synergy) with wound biology to highlight how infection drives chronicity and delay. They also suggest multidimensional therapeutic approaches combining systemic and localized strategies.

Key Highlights:

Pathogenesis of DFU/DFI: Infections impair healing by promoting persistent inflammation, extracellular matrix degradation, impaired angiogenesis, and immune dysregulation.

Biofilms & virulence: Biofilm formation and microbial virulence factors shield pathogens, resist antibiotics, and perpetuate inflammatory stimuli.

Polymicrobial dynamics: Gram-positive, gram-negative, anaerobes, and fungi interact within wound microbiomes, often synergistically worsening outcomes.

Therapeutic strategy framework: The authors advocate a combined approach—glycemic control, antimicrobial therapy tailored to pathogens, debridement, offloading, vascular support, and intelligent dressings.

Smart dressing evolution: Future wound dressings should integrate responsive systems (pH, ROS), controlled drug release, and functional enhancements like oxygen delivery or antimicrobial action.

Read the full article on Frontiers in Endocrinology

Keywords:
Qi Wang,
Chuyu Liu,
Jing An,
Jing Liu,
Yongpeng Wang,
Yulan Cai,
diabetic foot ulcer,
infection mechanisms,
chronic wounds,
smart dressings

Posted in Articles

The 2019 IWGDF diabetic foot infection guidelines to benchmark practice and improve the delivery of care in persons with diabetic foot infections

by admin on February 1, 2021

Posted in

by admin on August 8, 2019

…reports the results of a pilot study evaluating 11 patients with diabetic foot ulcers and 5 with venous stasis leg ulcers (all being refractory to at least 1 month of…

Application of Topical Sucralfate and Topical Platelet-Rich Plasma Improves Wound Healing in Diabetic Ulcer Rats Wound Model

One of the most devastating complications of diabetes mellitus is diabetic ulcers. Not only because these ulcers heal slowly, these ulcers may also cause disability and even results in limb loss.1 A diabetic ulcer is a chronic wound usually found in the soles of the diabetic patient’s feet. The occurrence of diabetic ulcers is mostly associated with neuropathy and vasculopathy in the form of the peripheral arterial disease which happens in the lower limb of the diabetic patient.2 Around 2% to 5% of all population in the world suffers from diabetic ulcers.3 The hyperglycemic state in diabetics causes molecular and physiological changes that cause diabetic ulcers to become difficult to heal, increasing its risk to secondary infection and potentially causing limb amputation if it is not treated properly.4 Diabetic ulcers account for nearly 90% of all lower limb amputation cases, with a reported mortality rate per year of 5.5% due to diabetic ulcers.

The main aim of diabetic ulcer therapy is to prevent extensive damage and secondary infection of diabetic ulcers, thereby minimizing the risk of further damage or even limb amputation. A thorough therapy for diabetic ulcers includes wound debridement, wound dressing, revascularization procedures, infection management, and ulcer off-loading … read more

Diabetic Foot Ulcers

Overview of Diabetic Foot Ulcers: Causes, Diagnosis, and Management

This detailed summary, adapted from a comprehensive article on Medscape, outlines the essential aspects of diabetic foot ulcers (DFUs), including risk factors, clinical presentation, diagnostic workup, and treatment approaches. Diabetic foot ulcers are a major complication of diabetes and contribute significantly to patient morbidity and healthcare costs.

Key Highlights:

Causes and Risk Factors: DFUs are commonly caused by peripheral neuropathy (loss of protective sensation), peripheral arterial disease (reduced blood flow), and structural foot deformities. These factors together increase the likelihood of ulcer formation and delay healing.

Clinical Presentation: DFUs typically present as open sores, especially on weight-bearing areas of the foot. Redness, swelling, discharge, and odor may indicate infection. Notably, pain is often absent due to neuropathy.

Diagnosis: Evaluation includes physical and neurological exams, vascular assessments (e.g., ABI), imaging (X-ray or MRI), and lab tests to detect infection or bone involvement.

Treatment: Effective care involves offloading pressure, regular wound debridement, appropriate dressings, infection management, tight glycemic control, and in some cases, surgery or revascularization. Multidisciplinary care is often required.

Prognosis: Up to 20% of DFUs may lead to lower-limb amputation. Recurrence is common, so prevention through foot care education and ongoing monitoring is critical.

With early detection and a coordinated treatment plan, many diabetic foot ulcers can be healed and serious complications avoided. Healthcare providers should remain vigilant for early signs in diabetic patients and implement evidence-based strategies to improve outcomes.

Read the full article on the Medscape website.

Keywords:
diabetic foot ulcers,
wound care,
debridement,
peripheral neuropathy,
offloading

Risk Factors for Multidrug-Resistant Organisms Infection in Diabetic Foot Ulcer

Diabetic foot ulcer (DFU) is one of the most serious complications of diabetes.1 Epidemiological investigation found that the global prevalence of DFU is 6.3%, and what is more troublesome is that DFU also has a high recurrence rate.3 Cohort studies have shown that DFU have a high mortality rate in both developed and developing countries, with a 5-year mortality rate of up to 42%. With high morbidity and mortality, DFU has been the main cause of nontraumatic lower-limb amputations. We have developed a model for predicting the risk of early DFU, which may potentially guide early intervention. Hyperglycemia impair immune cells activity in eliminating pathogens, while severe infection can cause stress hyperglycemia. The interaction of the two ways has resulted in a rapid development of diabetic foot infection (DFI) and sometimes a necrotizing abscess can be developed in just 6 days. Early empiric antibiotic treatment is necessary due to the long culture time of microorganisms and the lack of basic microbiology laboratories. But Multidrug-resistant organisms (MDROs) infection is easy to make antibiotic treatment failure, increasing the difficulty of diabetic foot treatment … read more

An Innovative Framework for Longitudinal Diabetic Foot Ulcer Diseases ….

DFU-Helper: An Innovative Framework for Longitudinal Diabetic Foot Ulcer Diseases Evaluation Using Deep Learning

Summary: Originally published in Applied Sciences (MDPI, 2023, 13(18):10310; DOI: 10.3390/app131810310) and recently archived on the HAL open science repository, DFU-Helper introduces a deep learning framework designed to address a practical gap in wound care: the absence of objective, longitudinal, computer-assisted assessment tools for diabetic foot ulcer (DFU) progression monitoring. With approximately 537 million people living with diabetes globally (projected to reach 783 million by 2045) and DFU representing a leading cause of lower limb amputation, continuous and meticulous patient monitoring is currently performed by medical practitioners on a daily basis — a resource-intensive process subject to inter-observer variability and lack of quantitative benchmarks between visits. DFU-Helper employs a Siamese Neural Network (SNN) architecture that learns feature-level similarity between DFU images across five distinct disease conditions: none, infection, ischemia, both (ischemia and infection combined), and healthy. At a patient’s initial consultation, an image is processed to compute distances from each class anchor point — generated using representative feature vectors — producing a comprehensive table and radar chart of disease-condition similarity distances. At subsequent visits, a new image is processed alongside the initial image, and DFU-Helper plots the progression trajectory, enabling visual and numerical comparison of disease state over time. Pseudo-labelling with a threshold of 0.9 yielded the best performance on the test dataset, achieving a Macro F1-score of 0.6455. The authors position DFU-Helper as a novel contribution distinguishable from prior DFU classification tools by its explicit focus on longitudinal follow-up rather than single-image diagnosis — to their knowledge, no existing tool at time of publication used deep learning comparably for DFU follow-up. The work was conducted collaboratively by researchers from Université des Mascareignes (Mauritius), XLIM/Université de Limoges (France), 3iL Ingénieurs (France), and Université de Limoges.

Key Highlights:

Siamese Neural Network architecture trained on DFU image dataset; classifies five disease states: none, infection, ischemia, both (ischemia + infection), and healthy; best Macro F1-score 0.6455 using pseudo-labelling (threshold 0.9)

Longitudinal assessment design: at initial visit, radar chart of class anchor distances generated; at subsequent visits, disease progression trajectory plotted — enabling objective numerical tracking between clinical consultations

Clinical gap addressed: current DFU monitoring relies on daily practitioner visual assessment; DFU-Helper provides quantitative, reproducible, clinician-assistive output for longitudinal wound state tracking

Five-condition classification covers the major wound state combinations relevant to DFU management — supports differentiated management decisions across infection, ischemia, combined, and clean wound states

Pseudo-labelling technique: semi-supervised approach using high-confidence unlabelled samples (threshold 0.9) to expand effective training data — practically relevant given the limited scale of annotated DFU datasets

Published in Applied Sciences (MDPI) 2023; deposited on HAL open science (hal-04554891v1) March 2026; open access CC BY 4.0; DOI: 10.3390/app131810310

Read full article

Keywords: diabetic foot ulcer AI deep learning, DFU wound monitoring technology, wound care computer vision, diabetic foot infection ischemia classification, longitudinal wound assessment AI, neural network wound imaging

Mohammud Shaad Ally Toofanee, Sabeena Dowlut, Mohamed Hamroun, Karim Tamine, Anh Kiet Duong, Vincent Petit, Damien Sauveron

Study Shows Increased Risk For Foot Infection-Related Hospitalizations In People With Diabetes

According to a recent publication in Diabetologia, there is an increased risk of infection-related hospitalization in patients with diabetes.1 This includes foot infections, for which the risk of hospitalization was nearly six times greater in patients with diabetes than those without. Remarkably, the risk for hospitalization in patients with diabetes for all infection types, including foot infection, respiratory infection, urinary tract infection, GI infection, sepsis, and post-operative infection was 67 percent higher than the non-diabetic group. In addition, the study authors noted a stronger association between diabetes and hospitalization related to infection in younger participants and Black patients … read more

Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence (DFU Biofilm)

Diabetic foot ulcers (DFU) are one of the most common reasons for hospitalization of diabetic patients and frequently results in amputation of lower limbs. Of the one million people who undergo non-traumatic leg amputations annually worldwide, 75% are performed on people who have type 2 diabetes (T2DM). The risk of death at 10 years for a diabetic with DFU is twice as high as the risk for a patient without a DFU. The rate of amputation in patients with DFU is 38.4%4. Infection is a common (>50%) complication of DFU. Emerging evidence underscores the significant risk that biofilm infection poses to the non-healing DFU. Biofilms are estimated to account for 60% of chronic wound infections. In the biofilm form, bacteria are in a dormant metabolic state. Thus, standard clinical techniques like the colony forming unit (CFU) assay to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent maleficent threat in wound care … read more

Lakewood-Amedex Enrolls First Patient in Phase 2 Clinical Trial for Patients with Chronic Diabetic Foot Ulcers (cDFU)

Lakewood-Amedex’s Second Clinical Trial for DFU Using New Nu-3 Gel Formulation Top Line Results Expected in December 2022

SARASOTA, Fla., April 5, 2022 /PRNewswire/ — Lakewood-Amedex, Inc., a privately held, clinical stage pharmaceutical discovery and development company advancing a broad portfolio of first-in-class antimicrobial and antifungal therapeutics called Bisphosphocins®, announced today that it has commenced its second Phase 2 study using Bisphosphocin Nu-3 antimicrobial in treating patients with diabetic foot ulcers (DFU). More than 34 million adults in the United States have diabetes mellitus (Source: CDC), and complications of DFU are responsible for about 85% of the non-traumatic lower extremity amputations per year, creating a tremendous morbidity, mortality, and financial burden on the healthcare system.

The Phase 2 study is a randomized, multi-center, double-blind, placebo-controlled, dose-escalating study to evaluate the safety and tolerability of topically applied Bisphosphocin Nu-3 gel on Type I or II diabetes mellitus patients with chronic DFU. During all clinic visits, the patients’ ulcers will be examined for any changes in the area and depth of the ulcer and microbiological control will be assessed.

Steve Parkinson, President & CEO of Lakewood-Amedex, said, “We are very pleased to be embarking upon our second clinical trial in treating DFUs. In our previous experience evaluating Nu-3 for the treatment of patients with infected diabetic foot ulcers, Nu-3 was well-tolerated with no reported adverse events related to treatment. While this previous dose-escalating study was not powered to generate statistically significant efficacy data, it did demonstrate an encouraging efficacy trend. Patients treated with 2% Nu-3 solution for seven days had a 65.5% reduction in ulcer area versus a 29.9% reduction in the placebo arm, as measured 14 days after treatment began. In addition, 62.5% of patients treated with 2% Nu-3 saw a reduction in the microbiological load, versus 20% in the placebo. Now our Phase 2 dose-escalating study will build on the foundation of the previous clinical trials by using a longer treatment duration of 28 days, a higher concentration of 5% followed by 10% Nu-3, as well as an improved Nu-3 gel formulation, all of which we expect will offer a better delivery of Nu-3 and treatment of nonhealing wounds. The impact of both topical and systemic infections remains a tremendous burden on the healthcare system. We believe our commitment to further developing our proprietary, antimicrobial Bisphosphocins technology platform with efficient, localized treatment of serious infections, often caused by antibiotic-resistant pathogens, both gram-positive and gram-negative, will enable healthcare providers to more safely and effectively address a host of bacterial infections that are currently proving challenging using conventional approaches.”

“Dr. Felix Sigal, who is one of the most distinguished specialists in the field of diabetic limb salvage, is on staff at both the Hollywood Presbyterian Medical Center and the California Hospital Medical Center. He focuses on wound care and diabetic limb salvage, while pursuing his interest in clinical research to enable better treatment options for his patients. We are pleased to report that Dr. Sigal has now enrolled the first patient in this Phase 2 study evaluating the use of Nu-3 gel in the treatment of diabetic foot ulcers,” said Sumita Paul, MD, MPH, MBA, Chief Medical Officer & Senior Vice President of Research & Development at Lakewood-Amedex Inc. “There will be 12 patients treated with the Nu-3 gel in each of the two cohorts and with a smaller placebo treated group.”

About Lakewood-Amedex, Inc.

Lakewood-Amedex is a privately held, clinical stage pharmaceutical company developing a broad portfolio of first-in-class antimicrobial and antifungal therapeutics called Bisphosphocins. The company’s products and technology are covered by an extensive patent portfolio consisting of granted and/or issued patents and pending patent applications covering many major pharmaceutical markets. The company’s lead therapeutic candidates are novel synthetic broad-spectrum antimicrobials proven to be effective in killing a wide range of Gram-positive, Gram-negative and antibiotic-resistant bacteria and all fungal strains tested. Nu-3 has already completed a Phase 2a clinical trial in patients with infected diabetic foot ulcers. For more information, https://lakewoodamedex.com.

This press release contains forward-looking statements that can be identified by terminology such as “expects,” “potential,” “suggests”, “may”, “will” or similar expressions. Such forward-looking statements regarding our business, which are not historical facts, are “forward-looking statements” that involve risk and uncertainties, which could cause the Company’s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. The Company does not undertake to update forward-looking statements to reflect the circumstances or events that occur after the date the forward-looking statements are made.

Contacts
Tiberend Strategic Advisors, Inc.

Investors
Lisa Sher
lsher@tiberend.com

Media
Dave Schemelia
dschemelia@tiberend.com

SOURCE Lakewood-Amedex Inc.

This article was originally published here

Helixmith Announces Phase 3 Study Results of Novel Gene Therapy Treatment for Diabetic Foot Ulcers

at 2021 Annual Meeting of Diabetic Foot Ulcer Conference (DFCon)
Data indicate that gene therapy appears to be effective, particularly in neuroischemic ulcers
SAN DIEGO, Oct. 22, 2021 /PRNewswire/ — Helixmith, a gene therapy company based in Seoul, Korea and San Diego, CA, announced today the results of a Phase 3 study for the treatment of diabetic foot ulcers with their novel gene therapy VM202 (Engensis) at the 2021 annual meeting of the Diabetic Foot Conference (DFCon) held in San Francisco and virtually. The study, “Gene Therapy for Diabetic Foot Ulcers: Analysis of a Randomized, Placebo-Controlled Phase 3 Study of Engensis (VM202), a Plasmid DNA Expressing Two Isoforms of Human Hepatocyte Growth Factor (HGF),” demonstrated a positive trend toward wound closure, potential healing effects and an acceptable safety profile. This is the first study using gene therapy for the treatment of diabetic foot ulcers. DFCon is the premier international, interdisciplinary diabetic foot conference in North America.

The purpose of the un-prespecified interim analysis was to evaluate the status of a 7-month Phase 3 study conducted to test the effect of intramuscular injection of Engensis into the calf muscles of participants having chronic nonhealing diabetic foot ulcers (DFU) with concomitant peripheral artery disease. In the interim ITT population (n=44), there was a positive trend toward wound closure in the VM202 group from month 3 to month 7. Ulcer closure effects were prominent, particularly in neuroischemic ulcer. In 23 patients having this type of foot ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4 and 5 (p = 0.0391, 0.0391, and 0.0361, respectively). Engensis seems to also improve hemodynamic features; a potentially clinically meaningful 0.15 increase in ABI was observed in the VM202 group at day 210 in ITT population (p=0.0776). The company believes that intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in treatment of chronic neuroischemic DFUs … read more

A Review: Matrix Metallopeptidase-9 Nanoparticles Targeted for the Treatment of Diabetic Foot Ulcers

Diabetes foot ulcers are a leading cause of death in diabetic individuals. There are very few medicines and treatments that have received regulatory clearance for this indication, and numerous compounds from various pharmacological classes are now in various stages of clinical studies for diabetic foot ulcers treatment. Multiple risk factors contribute to diabetic foot ulcers, including neuropathy, peripheral artery disease, infection, gender, cigarette smoking, and age. The present difficulties in diabetic foot ulcers treatment are related to bacterial resistance to currently utilized antibiotics. Inhibition of the quorum sensing (QS) system and targeting matrix metallopeptidase-9 (MMP-9) are promising. This study focuses on the difficulties of existing treatment, current treatment technique, and novel pharmacological targets for diabetic foot ulcer. The electronic data base search diabetic for literature on foot ulcers treatment was carried out using Science Direct, PubMed, Google-Scholar, Springer Link, Scopus, and Wiley up to 2021. Becaplermin, a medication that targets MMP-9, glyceryl trinitrate, which inhibits the bacterial quorum sensing system, probiotic therapy, and nano technological solutions are just a few of the novel pharmaceuticals being developed for diabetic foot ulcers … read more

Prevention of Infection in Peripheral Arterial Reconstruction of the Lower Limb

Prevention of Infection in Peripheral Arterial Reconstruction of the Lower Limb

Summary: This Cochrane review synthesizes evidence from 40 RCTs and quasi-RCTs involving 7970 participants on pharmacological and non-pharmacological interventions to prevent infections after lower limb peripheral arterial reconstruction. Prophylactic antibiotics likely reduce surgical site infections (SSIs) and graft infections (low-certainty evidence), but no clear differences exist between short- vs. long-duration regimens or antibiotic types (very low-certainty). Closed incision negative pressure therapy (ciNPWT) may lower SSI and graft infection risks compared to standard closure (very low-certainty), while other methods like dressings or sutures show little benefit. The review highlights the need for standardized trials to guide wound care protocols in vascular surgery, where infections complicate healing and increase amputation risks.

Key Highlights:

Antibiotics vs. none: Reduced SSIs (RR 0.20, 95% CI 0.11-0.34; NNT 9) and graft infections (RR 0.19, 95% CI 0.06-0.63; low-certainty).

Short vs. long antibiotics: No difference in SSIs (RR 0.75, 95% CI 0.40-1.40) or graft infections (very low-certainty).

ciNPWT vs. standard: Possible reduction in SSIs (RR 0.49, 95% CI 0.27-0.86) and graft infections (RR 0.55, 95% CI 0.19-1.59; very low-certainty).

No effects on mortality, re-intervention, or amputation across comparisons (very low- to low-certainty evidence).

Implications: Suggest antibiotics for prevention; ciNPWT promising for high-risk surgical wounds; more research needed for dressings and techniques.

Read full article

Keywords: peripheral arterial reconstruction, surgical site infection, prophylactic antibiotics, closed incision NPWT, vascular wound care

Experience in the use of dalbavancin in diabetic foot infection

Gema Navarro-Jiménez, Cristina Fuentes-Santos, Leonor Moreno-Núñez, Jesús Alfayate-García, Carolina Campelo-Gutierrez, Sira Sanz-Márquez, Elia Pérez-Fernández, María Velasco-Arribas, Rafael Hervás-Gómez, Oriol Martín-Segarra, Juan Emilio Losa-García

Objective: To describe the clinical experience with dalbavancin in the treatment of diabetic foot infection in a multidisciplinary unit of a second level hospital.

Methods: A retrospective, descriptive study was made with all patients with diabetic foot infection treated with dalbavancin in the Diabetic Foot Unit of Hospital Universitario Fundación Alcorcón, covering the period from September 2016 to December 2019. Demographic parameters and comorbidities, characteristics of the infection and treatment with dalbavancin were recorded. The cure rate is estimated at 90 days after finishing the treatment … read more

Multifaceted Antibiotic Resistance in Diabetic Foot Infections: A Systematic Review

Multifaceted Antibiotic Resistance in Diabetic Foot Infections: A Systematic Review

Summary: This systematic review and limited meta-analysis (2014–2024) analyzed 28 studies to evaluate bacterial prevalence and antibiotic resistance patterns in diabetic foot infections (DFIs). The findings highlight high rates of multidrug resistance (MDR), associations with comorbidities, and the importance of culture-guided therapy in preventing treatment failure.

Key Highlights:

Common pathogens: Staphylococcus aureus was the most frequent isolate, followed by Pseudomonas, Enterococcus, Enterobacter, and Escherichia coli.

Resistance trends: High rates of both mono- and multidrug resistance were observed, with Acinetobacter showing the greatest MDR burden.

Comorbidity correlations: Dyslipidemia, hypertension, nephropathy, peripheral vascular disease, prior amputation, and smoking were strongly linked with resistance profiles.

Study limitations: Most studies originated from China and Malaysia, with male patients overrepresented, which may limit generalizability.

Clinical impact: Empiric antibiotic use without culture testing risks treatment failure in MDR infections. Regular antibiogram surveillance and individualized therapy are essential for effective management.

Read the full article in Microorganisms (MDPI)

Keywords:
Weiqi Li,
Oren Sadeh,
Jina Chakraborty,
Emily Yang,
Paramita Basu,
Priyank Kumar,
diabetic foot infection,
antibiotic resistance,
multidrug resistance,
antimicrobial stewardship

Corstrata Announces Availability of New Tech Empowered

Diabetic Foot Ulcer & Amputation Prevention Solution

SAVANNAH, GA. (PRWEB) JULY 10, 2018

CORSTRATA, a provider of digital healthcare IT solutions and services for wound management, announced today the availability of the company’s new Diabetic Foot Ulcer & Amputation Prevention Solution. The Solution is designed to prevent costly and complicated wounds from developing and is the first comprehensive program that leverages state-of-the-art technology and a team of top-tier Board Certified Wound Clinicians for the early detection of ulcers that often lead to hard-to-heal wounds and amputations among the growing U.S. diabetic population.

Diabetic foot ulcers (DFUs) are a common, limb-threatening and expensive complication of Type 1 and Type 2 diabetes. Today, more than 30M people in the U.S. have diabetes and more than 1.7M suffer from new DFUs per year with a 40% reulceration rate. 80K of these diabetics ultimately require an amputation and the risk of death at 5 years for DFU patients is 2.5 times as high as the risk for a patient with diabetes without a foot ulcer.

“The Corstrata Diabetic Foot Ulcer and Amputation Solution offers an important advancement in both the detection and prevention of one of the most costly and complex types of wounds to heal,” said Katherine Piette, Chief Executive Officer and Founder, Corstrata. “The mobile and remote monitoring technology combined with our deep clinical expertise in diabetic foot ulcer prevention and wound management, enable us to help payers and value-based care organizations significantly reduce their risk and costs associated with ulcerations in diabetic members.”

The Corstrata program is a comprehensive end-to-end technology-enabled solution that uses the HIPAA compliant, Corstrata Intervention & Engagement mobile app and the industry’s only FDA approved smart thermometric mat. The Solution is designed to help value-based care organizations and payers with the following:

    High-Risk Patient Identification

    Program Enrollment

    Daily Remote Patient Monitoring

    Member Engagement & Education

    Timely Evidenced-Based Intervention for Prevention of DFU

    Empowering Members for Self-Management

“Research indicates that the use of early detection technology, coupled with evidence-based interventions, can prevent 75% of foot ulcers in this high-risk population,” said Joseph Ebberwein, Chief Financial Officer and Founder, Corstrata. Lower extremity amputation studies and clinical trials have shown that Diabetic Foot Ulcer and Amputation prevention solutions can greatly reduce costly hospital visits and procedures associated with ulcerations and amputations, including:

    Reduction in Hospitalizations

    Decreased Hospital Days

    Reduction in Amputations

    Decreased Emergency Room Visits

    Decreased Foot Ulcer Recurrence

Corstrata was also recently named a semifinalist in the T1D Exchange 2018 Diabetes Innovation Challenge. A poster depicting the Corstrata DFU solution was showcased at the public event on May 21, 2018, at the Royal Sonesto Boston in Cambridge, MA.

Learn more about the Corstrata Diabetic Foot Ulcer and Amputation Prevention Solution at Corstrata.com/Diabetic-Foot-Ulcer-Prevention.

About Corstrata
Corstrata was founded in 2015 by two passionate healthcare experts with the goal of improving access to technology enabled, evidence-based care for patients with chronic wounds, which currently costs the U.S. $33B annually. Home health agencies, hospices, self-funded employers, clinically integrated networks of doctors and related practitioners (CINs), and third-party payers (Medicare Advantage, Medicaid MCOs) can benefit from Corstrata’s unique combination of professional expertise, digital technologies and telemedicine to treat wound patients and support practitioners anywhere, any time. The company delivers a Comprehensive Wound Care Management Program, Wound Patient Consultations, and specific services such as wound program assessment, formulary design, treatment guidelines assessment, wound documentation review, and practitioner education. Wound program development is available for Pressure Injury (Ulcer) Prevention and Management, Diabetic Foot Ulcer Prevention and Management, Ostomy Care and Management, and Palliative Wound Management. For more information about Corstrata, visit Corstrata.com.

From PRWeb

Staphylococcus aureus Toxins and Diabetic Foot Ulcers

Role in Pathogenesis and Interest in Diagnosis

Infection of foot ulcers is a common, often severe and costly complication in diabetes. Diabetic foot infections (DFI) are mainly polymicrobial, and Staphylococcus aureus is the most frequent pathogen isolated. The numerous virulence factors and toxins produced by S. aureus during an infection are well characterized. However, some particular features could be observed in DFI. The aim of this review is to describe the role of S. aureus in DFI and the implication of its toxins in the establishment of the infection. Studies on this issue have helped to distinguish two S. aureus populations in DFI: toxinogenic S. aureus strains (harboring exfoliatin-, EDIN-, PVL- or TSST-encoding genes) and non-toxinogenic strains. Toxinogenic strains are often present in infections with a more severe grade and systemic impact, whereas non-toxinogenic strains seem to remain localized in deep structures and bone involving diabetic foot osteomyelitis. Testing the virulence profile of bacteria seems to be a promising way to predict the behavior of S. aureus in the chronic wounds … read more

Healthcare-Acquired Wound Infections and Antimicrobial Resistance – webinar

Healthcare‑Acquired Wound Infections & Antimicrobial Resistance: Embracing a Multidisciplinary Team Approach

Presented on June 19, 2025, this free, on‑demand webinar by WoundSource addresses the growing risks of hospital‑acquired wound infections and the escalating problem of antimicrobial resistance (AMR). Featuring insights for clinicians on integrating multidisciplinary strategies for prevention, management, and stewardship.

Key Highlights:

Rising Infection Risks: Covers the prevalence and serious complications associated with healthcare‑acquired wound infections, including surgical site infections, device‑related wounds, and pressure injuries. :contentReference[oaicite:1]{index=1}

Antimicrobial Resistance Challenge: Discusses how multidrug-resistant organisms complicate treatment, leading to increased morbidity, mortality, and healthcare costs. :contentReference[oaicite:2]{index=2}

Multidisciplinary Protocols: Emphasizes collaborative best practices involving infection control experts, microbiologists, pharmacists, nursing staff, and wound specialists to optimize prevention and management.

Stewardship Strategies: Promotes antimicrobial stewardship programs, including robust surveillance, appropriate antibiotic selection, targeted therapy, and review of antibiotic duration to minimize resistance pressure.

Clinical Practice Adaptations: Highlights the use of evidence‑based dressings, modality selection, debridement protocols, and early identification to reduce colonization and infection rates.

Watch the full webinar on the WoundSource website.

Keywords:
healthcare-acquired infections,
antimicrobial resistance,
multidisciplinary team,
antimicrobial stewardship,
wound infection prevention

Response to: Remote Diabetic Foot Temperature Monitoring for Early Detection of Diabetic Foot Ulcers

A Cost-Effectiveness Analysis
We read with pleasure the recent article in your journal on the cost-effectiveness of remote diabetic foot temperature monitoring by Brooks et al.1 Diabetic foot ulcers pose a major healthcare burden, and insight into cost-effectiveness of treatments in this field is scarce, especially in preventing foot ulcers.2 Studies with original data are clearly preferred to inform clinicians, researchers and policy-makers on the potential cost-savings and health gains of preventative interventions. But modelling analyses such as by Brooks et al can provide relevant insights … For modelling analyses to be meaningful, assumptions must be based on both published evidence and clinical reasoning, and must be reasonable and logical. For a cost-effectiveness analysis on remote foot temperature monitoring, two assumptions are key … read more

A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence

The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence

Summary: Published March 17, 2026 in Diabetology (MDPI), this PRISMA 2020-compliant systematic review and random-effects meta-analysis from a Greek private practice clinician (Elefsina) and David G. Armstrong (USC Keck School of Medicine / SALSA) addresses a specific and clinically actionable gap: what is the actual 12-month recurrence rate for diabetic foot ulcers (DFUs) in adults with confirmed remission at baseline? The widely cited benchmark of approximately 40% recurrence at one year — drawn from Armstrong, Boulton, and Bus’s landmark 2017 NEJM review — has been critiqued for combining heterogeneous follow-up intervals and imprecise definitions of remission. This analysis restricted pooling to three cohorts with confirmed remission (defined as fully healed and ulcer-free at baseline) and an exact 12-month outcome: the overall DIATIME trial arm (López-Moral et al., 2025) and two prospective remission cohorts from Germany and the Czech Republic (Ogurtsova et al., 2021), totalling 469 participants. Using a DerSimonian–Laird random-effects model on the logit scale, the pooled 12-month recurrence proportion was 29.3% (95% CI 24.9–34.1%), with low heterogeneity (I² ≈ 17%). Individual cohort rates ranged from approximately 25% (Czech) to 34% (Czech/German overall). This estimate, approximately one in three adults, is lower than the broadly quoted ~40% figure but still clinically high enough to support structured surveillance. The authors frame DFU remission through a cancer-survivorship lens: like cancer remission, healed DFU does not mean restored tissue normalcy — the previously ulcerated site remains molecularly vulnerable, with altered collagen, impaired microcirculation, and reduced mechanical tolerance. They note that the DIATIME trial also demonstrates that 4-week surveillance intervals significantly outperform 8- and 12-week intervals in preventing recurrence. The GRADE certainty of evidence is rated low, and the review was not PROSPERO-registered, though no deviations from the pre-specified analytic plan occurred. Larger, preregistered, multicenter cohorts with standardised definitions are explicitly called for.

Key Highlights:

Pooled 12-month DFU recurrence in confirmed-remission populations: 29.3% (95% CI 24.9–34.1%; k=3 cohorts, n=469) — approximately one in three adults; lower than the widely cited ~40% benchmark, reflecting stricter remission definition and fixed 12-month timepoint

Individual cohort recurrence range: ~25% (Czech cohort, Ogurtsova 2021) to 33.8% (DIATIME overall arm, López-Moral 2025); DIATIME showed 18.4% recurrence with 4-week screening vs. 46% with 12-week screening — surveillance frequency matters significantly

Remission ≠ healed: the authors emphasise that apparent skin closure masks persistent molecular vulnerability — altered collagen structure, impaired microcirculation, inflammatory priming, and reduced mechanical tolerance — consistent with the survivorship model

Cancer survivorship parallel: three-year DFU recurrence (~58%) and reintervention rates for CLTI (~50%) are comparable to those of advanced breast, colorectal, prostate, and lung cancers (Armstrong et al., 2025, Int Wound J) — normalisation of these rates in diabetic foot disease is a recognised systemic problem

Technology-assisted prevention: DIATEMP RCT found at-home plantar temperature monitoring reduced recurrence at any foot site, especially when patients reduced activity upon hotspot detection; intelligent insole systems with personalised pressure feedback reduced high-pressure events after ~16 weeks of use

Limitations: GRADE low-certainty evidence; small k (3 cohorts); review not PROSPERO-registered; disagreements resolved by two-reviewer consensus without third-party adjudication; DIATIME data collapse across arms may underestimate baseline risk

Read full article

Keywords: DFU recurrence remission, diabetic foot ulcer survivorship, 12-month DFU outcomes, post-healing diabetic foot surveillance, meta-analysis diabetic foot ulcer, DIATIME trial DFU

George Theodorakopoulos, David G. Armstrong

Hyperbaric oxygen therapy for chronic diabetic foot ulcers: An overview of systematic reviews

Researchers assessed clinical evidence of hyperbaric oxygen therapy in the management of diabetic foot ulcers, via this overview of systematic reviews. They analyzed systematic reviews (SRs) assessing the impacts of hyperbaric oxygen therapy in individuals with diabetic foot ulcer. Inclusion criteria were fulfilled by 11 SRs/MAs. They found limited clinical evidence in favor of hyperbaric oxygen therapy in the management of diabetic foot ulcers, routine application of hyperbaric oxygen therapy to all patients with diabetic foot ulcers, particularly those with non-ischemic diabetic foot ulcers, is not advised. Certain potential of hyperbaric oxygen therapy to promote ulcer healing as well as decrease amputation rate in patients with ischemic diabetic foot ulcers has been observed, but because these results are supported by low quality and small quantity of the SRs/MAs, widespread recommendations require high-quality studies with rigorous … read more

The analysis for time of referral to a medical center among patients with diabetic foot infection

Diabetic foot infection (DFI) is a limb- and life-threatening complication for diabetic patients needing immediate and comprehensive treatment. Early referral of DFI patients to a diabetic foot center is recommended but there appears limited validated evidence, with the association between referral time and clinical outcomes of limb- preservation or in-hospital mortality still lacking … This retrospective research studied consecutive type 2 diabetic patients with DFI treated at the major diabetic foot center in Taiwan from 2014 to 2017. Six hundred and sixty-eight patients presented with limb-threatening DFI. After stratifying their referral days into quartiles, the demographic information and clinical outcomes were analyzed … read more

Identification and management of infection in diabetic foot ulcers

Diabetic foot ulcers (DFUs) are rising in prevalence globally, and particularly in the Gulf region. Infection remains a common and serious complication in managing DFUs. A need was identified for local guidelines that considered cultural and religious practices in the Gulf region, as well as clinical issues. This consensus document aims to provide practitioners with guidance on identifying and managing DFUs, which can be directly applied to local practice … download (pdf)

Newly Published RCT Shows MolecuLight Fluorescence Point-of-Care Imaging Improved 12-Week Wound Healing by 204% in Diabetic Foot Ulcers

Study Confirms the Utility of MolecuLight to Inform Clinicians to the Presence and Location of Clinically Significant Bacteria and Improves Treatment Plans & Outcomes over Conventional Diagnostic Methods

LEEDS, UK and TORONTO, July 13, 2022 /PRNewswire/ – MolecuLight Inc., the leader in fluorescence imaging for detection and localization of elevated bacterial load in wounds, announced the publication of an independent, blinded randomized controlled trial in Diabetes Care. The publication on this 56-patient trial, titled “The use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial“1 reported that the use of a MolecuLight i:X® device to visualize the presence of elevated bacterial burden in wounds doubled 12-week wound healing rates (204%) in diabetic foot ulcer patients over standard-of-care alone.

Diabetes is a significant global health ailment: over 416 million people have diabetes worldwide2 and 25% of these patients develop a diabetic foot ulcer (DFU)3, greatly diminishing quality of life and increasing the need for costly and extended treatment. In the UK, the NHS spends £1 billion ($1.25 billion US) annually on DFU care and management24.

“As a clinician in wound care, especially when managing patients with chronic wounds, the holy grail is improvement in wound healing rates”, says David Russell, Associate Professor in Vascular Surgery at University of Leeds and lead author in the study. “In our randomized controlled trial, the results were impressive – the use of a MolecuLight device to inform our wound care decision-making helped us double the number of wounds that were healed at 12 weeks. This has benefits for the patient and our healthcare system.”

Patients were stratified into two groups, one in which the MolecuLight device was not used, and one in which clinicians used the MolecuLight device bi-weekly to assess diabetic foot ulcers for the presence of elevated bacterial burden. For the MolecuLight group, fluorescence imaging was performed after treatment. Fluorescence indicated the presence of elevated bacterial burden in over 80% of the wounds. Additional treatment based on imaging findings was performed as the discretion of the clinician, and most often included further debridement focused on the regions with elevated bacterial loads. Importantly, there was no increase in antibiotic prescribed in the MolecuLight group.

Alongside the impressive 2-fold improvement in healing rates, this study showed an association between baseline fluorescence and wound outcomes. Of the patients with negative fluorescence images at the baseline visit, 53.9% healed at 12-weeks, versus 37.5% with positive baseline fluorescence images. In other words, patients were 36% less likely to heal at 12 weeks if their wound was positive for high bacterial loads at the beginning of their treatment, as depicted by MolecuLight. Wound area reduction was superior in the MolecuLight arm and patient quality of life diverged toward improvement in the MolecuLight arm at 4 weeks and toward deterioration in the control arm at 12 weeks.

“To improve decision-making and care with DFU patients we must be able to measure what we manage. The MolecuLight i:X, as illustrated by the results in this RCT, is a powerful tool for screening DFUs for infection as well as monitoring new or worsening bacterial burden over time”, says David G. Armstrong, Professor of Surgery, Director of the Southwestern Academic Limb Salvage Alliance (SALSA) at Keck School of Medicine of the University of Southern California as well as the US-appointed delegate to the International Working Group on the Diabetic Foot (IWGDF). “This new study provides further data for the improved healing rates and improved patient care that can be achieved in a clinic with routine use of fluorescence imaging to detect wound bacteria.”

“We congratulate Dr. Russell and the team at Leeds for their excellent study and publication that shows the utility of MolecuLight to detect elevated bacterial burden and to inform clinical decision-making at the point-of-care”, says Anil Amlani, MolecuLight’s CEO. “A doubling of 12-week wound healing is a significant outcome and is consistent with what thousands of wound care clinicians are experiencing worldwide, that MolecuLight enables clinicians to deliver superior, proactive bacterial/infection management that improves wound outcomes”.

The Leeds Diabetes Limb Salvage service is now using the MolecuLight device to image all patients with wounds that are failing to achieve a healing trajectory within 4 weeks. To help manage patient volumes, patients who are negative with MolecuLight are triaged, and are then referred to community care as their wounds are considered manageable and able to achieve a healing trajectory.

This new RCT is part of a broad body of clinical evidence showing the many benefits of the MolecuLight i:X and DX devices across the range of wound care applications to help inform and improve clinical decision-making. This list of clinical evidence includes over 60 peer-reviewed publications and 1,500 studied wound patients.

Rahma S et al. Diabetes Care 2022;45(7):1601–1609

Diabetes UK: Diabetes Prevalence, www.diabetes.org.uk/professionals/position-statements-reports/statistics/diabetes-prevalence-2019

Armstrong AG et al. The New England Journal of Medicine, 2017; 376:2367 – 75

Kerr, M, 2017, www.diabetes.org.uk/resources-s3/2017-11/diabetes%20uk%20cost%20of%20diabetes%20report.pdf

About MolecuLight Inc.
MolecuLight Inc. is a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s suite of commercially released devices, including the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, provide point-of-care handheld imaging devices for the global wound care market for the real-time detection and localization of elevated bacterial load in wounds and for digital wound measurement. MolecuLight procedures performed in the United States can benefit from an available reimbursement pathway including two CPT® codes for physician work to perform “fluorescence imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant unmet needs including food safety, consumer cosmetics and other key industrial markets.

For more information, contact:
Rob Sandler
Chief Marketing Officer
MolecuLight Inc.
T. +1.647.362.4684
rsandler@moleculight.com
www.moleculight.com

Venous stasis ulcers, arterial ulcers, diabetic neuropathic ulcers, pressure …

Are You Confident of the Diagnosis?

Leg ulcers are skin lesions with full-thickness loss of epidermis and dermis on the lower extremities. Among a wide variety of etiologies for chronic leg ulcers, four common types are venous stasis ulcers, arterial ulcers, diabetic neuropathic ulcers, and pressure ulcers. By definition, chronic leg ulcers last greater than 6 weeks. Acute ulcers such as traumatic wounds undergo normal healing in healthy patients without the need for further treatment. As a result, only chronic leg ulcers will be discussed here.

Patients with venous leg ulcers commonly complain of swelling and aching of the legs that is worse at the end of the day and improves with leg elevation. The medial lower leg is the most common site. The borders of venous ulcers are typically saucer-shaped, initially with a shallow wound base. The surrounding skin often exhibits pitting edema, induration, hemosiderosis, varicosities, lipodermatosclerosis, atrophie blanche, and/or stasis dermatitis read more

Pandemic leads to changes in delivery of care for diabetic foot infections

The COVID-19 pandemic led to early disruptions in diabetic foot care during lockdowns, and cases of diabetes-associated foot infections increased after lockdowns were lifted, according to a speaker … Brian Schmidt, DPM, an assistant professor of internal medicine in the division of metabolism, endocrinology and diabetes at the University of Michigan School of Medicine, said during a virtual presentation at the American Diabetes Association Scientific Sessions that poor messaging at the start of the COVID-19 pandemic may have kept many patients with diabetic foot conditions from contacting providers about complications, leading to increases in infections after stay-at-home orders were lifted … read more

Trends and Healthcare Innovations in Plantar Pressure Management for Diabetic Foot Ulcers

Global Research Trends and Healthcare Innovations in Plantar Pressure Management for Diabetic Foot Ulcers: A 25-Year Bibliometric and Visual Analysis

Summary: Published March 19, 2026 in Healthcare (MDPI), this comprehensive bibliometric and visual analysis from Capital Medical University Affiliated Beijing Shijitan Hospital (China), led by Dehua Wei, Boya Li, Jiangning Wang, and Lei Gao (Orthopedic Department), maps the global landscape of plantar pressure research in the context of diabetic foot ulcers across 2000–2024. Using Web of Science Core Collection data (2,110 articles after screening from 2,518 initial records), and analysis tools including VOSviewer, CiteSpace, and Scimago Graphica, the study provides the first dedicated bibliometric synthesis of this specific subdomain. Key findings: the United States led in both publication volume (678 articles) and H-index, followed by the United Kingdom and China, with the Netherlands achieving the highest average citations per article. David G. Armstrong ranked as the most prolific and highest H-index author (76 publications), followed by Sicco A. Bus (52) and Lawrence A. Lavery (40). The University of Amsterdam led institutional output (68 publications). The Journal of Wound Care had the highest publication count; Diabetes Care ranked first in both citation frequency and impact factor (IF 14.8). Keyword co-occurrence analysis identified 12 major clusters spanning: diabetic foot pathophysiology and amputation risk, microcirculation and vascular management, evidence-based management and guidelines, ischemia and regenerative repair, biomechanical risk factors, foot biomechanics and modeling, prevention and offloading interventions, NPWT and therapeutic technology, wound nursing and efficacy evaluation, chronic wounds and biofilm, ulcer classification and regenerative medicine, and population-level epidemiology. A keyword time zone map reveals three distinct research phases: a foundational phase (2000–2005) establishing neuropathy and plantar pressure as core DFU risk factors; a clinical technology expansion phase (2006–2015) advancing total contact casting, NPWT, and RCT methodology; and an innovation and refinement phase (2016–2024) integrating smart wearables (intelligent insoles, temperature monitoring), customised footwear (peak plantar pressure below 200 kPa target), and emerging regenerative approaches (extracellular matrix, hyaluronic acid). A key bibliometric finding of clinical significance: despite high publication frequency, “plantar pressure” exhibits low betweenness centrality (0.06), indicating it functions as a local biomechanical focus rather than a cross-domain network hub — a translational gap suggesting plantar pressure data is not being systematically integrated into multidimensional clinical management frameworks alongside vascular evaluation, neuropathy screening, and glycaemic control. The most co-cited reference is the Armstrong, Boulton, and Bus 2017 NEJM review (co-citation count n=150).

Key Highlights:

25-year dataset: 2,110 articles (WoS, 2000–2024); sustained growth from ~50 publications/year (2000) toward 150+/year (2024); US, UK, and Netherlands as dominant contributors; China and India showing rapid recent acceleration

Key opinion leaders: David G. Armstrong (76 publications, highest H-index), Sicco A. Bus (52), Lawrence A. Lavery (40), Andrew J.M. Boulton; Armstrong 2017 NEJM review is the most co-cited document (n=150) in the entire corpus

Translational gap identified: plantar pressure has high publication frequency but low betweenness centrality (0.06) in the co-occurrence network — meaning it functions as a local biomechanics topic rather than bridging to broader clinical outcome, vascular, or care-coordination frameworks; the authors call for integration of pressure data with comprehensive risk stratification tools

Offloading evidence: total contact casting remains gold standard for healing neuropathic plantar DFUs; custom diabetic footwear reduces 18-month recurrence by ~50%; Achilles tendon lengthening reduces forefoot ulcer recurrence by 75% in selected cases; peak in-shoe pressure target of <200 kPa for recurrence prevention

Smart technology trends (2016–2024 burst terms): custom-made footwear (burst 2019–2020), wound care (burst 2021–2024), epidemiology (burst 2022–2024); emerging: continuous plantar temperature monitoring, intelligent insole pressure feedback systems, remote monitoring platforms — all gaining publication volume but still limited by patient acceptance, alert fatigue, and adherence barriers

Global health equity gap: US and European institutions lead publication output and establish most guidelines; China and India are rapidly expanding contributions; but access to smart insoles, custom footwear, and multidisciplinary foot teams remains inequitable globally — the authors call for locally adaptable, cost-effective offloading solutions

Read full article

Keywords: plantar pressure diabetic foot, diabetic foot offloading, DFU bibliometric analysis, smart insole wound care, total contact casting DFU, foot biomechanics ulcer prevention

Dehua Wei, Boya Li, Jiangning Wang, Lei Gao

Optimizing Diabetic Foot Ulcer Care: Four Steps to Save Limbs Worldwide

Optimizing Diabetic Foot Ulcer Care: Four Steps to Save Limbs Worldwide

Keck Medicine of USC outlines a comprehensive, four-step approach to diabetic foot ulcer (DFU) management, aiming to reduce the global incidence of lower-limb amputations. This strategy emphasizes early detection, interdisciplinary care, and patient empowerment to enhance outcomes for individuals with diabetes.

1. Establishing a “Hot Foot Line”: A dedicated hotline facilitates rapid triage of patients presenting with diabetic foot infections or ischemia, ensuring immediate assessment by a specialized limb-salvage team. This prompt intervention can significantly decrease the risk of major amputations.

2. Developing Wound-Healing Clinics: Specialized outpatient clinics focus on active tissue loss, employing advanced modalities such as total contact casting, vascular diagnostics, and surgical debridement. These clinics aim to expedite healing and reduce hospitalization rates.

3. Establishing Remission Clinics: Post-healing, remission clinics work to prevent ulcer recurrence through patient education, biomechanical evaluations, and preventive interventions. Tools like pressure-relieving footwear and thermal monitoring devices are utilized to maintain ulcer-free periods.

4. Implementing Screening Clinics: Annual foot screenings assess risk factors like neuropathy and peripheral artery disease. Early identification allows for timely referrals to appropriate care pathways, including remission or wound-healing clinics, thereby preventing the progression to limb-threatening conditions.

This model has demonstrated success at Keck Medicine of USC and is adaptable to various healthcare settings globally. By integrating these steps, healthcare systems can proactively manage chronic conditions, ultimately saving limbs and improving quality of life for patients with diabetes.

Read the full article on the Keck Medicine of USC website.

Keywords:
Diabetic foot ulcers,
Foot ulcer care,
Limb salvage,
Amputation prevention,
Keck Medicine of USC,
David G. Armstrong

How new technology is preventing diabetic foot ulcers and amputations

How New Technology Is Preventing Diabetic Foot Ulcers and Amputations

Published June 5, 2025 by the Disabled American Veterans (DAV), this article highlights how the VA partnered with Podimetrics to roll out the **SmartMat®**, a temperature-sensing floor mat designed to detect diabetic foot ulcer (DFU) risk before wounds appear—aiming to reduce amputation and improve veteran health.

Key Highlights:

Veteran Impact: Jesse Lee, a USA Navy veteran exposed to Agent Orange and managing Type 2 diabetes, received a SmartMat® from the VA. The simple 30‑second foot scan helps identify early “hotspots” (≥2.2 °C difference sustained for two days) that predict ulcer formation.

Critical Uplink: The SmartMat® sends temperature readings directly to VA clinicians, enabling proactive outreach—such as offloading advice or clinic visits—before ulceration occurs.

Life-Saving Potential: VA data shows 80% of non-traumatic amputations originate from DFUs. The five-year mortality rate post-first ulcer is ~43–70%. Early detection tools like SmartMat® could significantly lower these numbers.

Partnership and Innovation: Podimetrics CEO Dr. Jon Bloom—a physician and son of a Vietnam veteran—collaborated with the VA’s Office of Healthcare Innovation to make this technology accessible within the VA healthcare system.

Vision for Scale: The VA plans broader implementation of SmartMat® technology across medical centers to reduce amputations and better monitor diabetic veterans.

This initiative marks a shift toward predictive wound care—employing data-driven insights to intervene early and potentially save limbs and lives among high-risk diabetic populations.

Keywords:
SmartMat,
Podimetrics,
Jesse Lee,
Dr. Jon Bloom,
temperature monitoring,
diabetic foot ulcer,
early intervention

Read the full article on DAV.org

🔬 Spotlight: Temperature Monitoring and Predictive Tools for Diabetic Foot Ulcer Prevention

Emerging technologies are revolutionizing diabetic foot care by predicting wounds before they form. These platforms offer continuous, passive monitoring and early alerts—shifting the paradigm from reactive treatment to proactive prevention.

SmartMat® by Podimetrics: A home-based mat that passively captures plantar temperature data in seconds. Consistent temperature asymmetries (≥2.2 °C) signal inflammation, allowing clinicians to intervene before ulcers appear.

Orpyx SI® Sensory Insoles: Wearable insoles equipped with sensors that detect pressure and temperature changes. Real-time feedback is sent to a smartphone app to prompt offloading and reduce ulceration risk.

Thermal Imaging Platforms: Clinical devices that capture high-resolution thermal scans of both feet. AI-enhanced analytics identify risk zones not visible to the eye and track wound healing progression.

Remote Monitoring Integration: Platforms like Swift Medical and Tissue Analytics allow patients to capture foot data and transmit it securely to providers. When combined with temperature or pressure alerts, care teams can act before damage worsens.

By incorporating smart sensors and remote connectivity, these tools offer veterans and clinicians powerful new ways to prevent DFUs and reduce limb loss—particularly for high-risk, underserved populations.

Diabetic Foot Ulcer Classification and Assessment

Classification of Diabetic Foot Ulcers

Historically, classification and subsequent treatment of DFUs do not adequately include management of concomitant ischemia of peripheral arterial disease (PAD). The Wagner Diabetic Foot Ulcer Grade Classification System, which has been in use since its inception in the 1970s, did not have the capacity to describe ischemic components of DFU. The University of Texas Diabetic Foot Ulcer Classification System, PEDIS (perfusion, extent, depth, infection, and sensation), WIfI Threatened Limb (Wound/Ischemia/Foot Infection), and SINBAD (Site, Ischemia, Neuropathy, Bacterial infection, And Depth) are classification systems that utilize degrees of ischemia as a contributing factor.

At present, subclassification of DFUs can be divided into three categories: neuropathic, ischemic, and neuroischemic. The most prevalent of the three is the neuroischemic DFU, which comprises approximately 50% of such ulcerations. Organization and reproducibility of the assessment process are crucial to success. Workups should include identification of intrinsic and extrinsic factors, both modifiable and non-modifiable. We will review appropriate assessments by using a typical history and physical examination format … read more

Characteristics of Diabetic Foot Ulcer Patients Pre- and During COVID-19 Pandemic

Lessons Learnt From a National Referral Hospital in Indonesia

Abstract
Background: Diabetic foot ulcer (DFU) is one of the most terrifying diabetic complications for patients, due to the high mortality rate and risk for amputation. During the COVID-19 pandemic, many diabetic patients limited their visits to the hospital, resulting in delays for treatment especially in emergency cases.

Objective: This study aimed to compare the characteristics of patients with DFU pre- and during COVID-19 pandemic period. Methods: This study was a retrospective cohort study using foot registry data. We compared our patients’ characteristics pre-COVID-19 pandemic period (1 March 2019-28 February 2020) and during COVID-19 pandemic period (1 March 2020-28 February 2021).

Results: Cohorts of 84 and 71 patients with DFU pre- and during COVID-19 pandemic period, respectively, were included in this study. High infection grade (66.7% vs 83.1%, P = .032), osteomyelitis event (72.6% vs 87.3%, P = .04), leukocyte count (15 565.0/μL vs 20 280.0/μL, P = .002), neutrophil-to-lymphocyte ratio (7.7 vs 12.1, P = .008), waiting time-to-surgery (39.0 h vs 78.5 h, P = .034), and number of major amputation (20.2% vs 39.4%, P = .014) were significantly higher during the COVID-19 pandemic period.

Conclusion: During the COVID-19 pandemic, patients with DFU had more severe infection, higher proportion of osteomyelitis, longer waiting time for getting surgical intervention, and higher incidence of major amputation.

Keywords: COVID-19; amputation; diabetic foot ulcer; infection; mortality; waiting time to surgery.
… from PubMed

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Mapping the Footprint of Progress: A Decade of Diabetic Foot Ulcer Research

Mapping the Footprint of Progress: A Decade of Diabetic Foot Ulcer Research

In a new bibliometric analysis featured on DiabeticFootOnline, researchers review the global expansion of diabetic foot ulcer (DFU) research over the past decade (2014–2023), uncovering trends in publication volume, country contributions, scholarly influence, and emerging scientific themes.

Study Highlights:

Exponential Growth: Annual DFU-related publications increased nearly threefold, from approximately 387 in 2014 to over 1,060 by 2023—reflecting growing scientific and clinical focus.

Global Leaders: The United States led output (accounting for over 25% of total publications), with China, England, Australia, and Italy also showing strong upward trends. Major academic contributors included the University of Texas System and the University of Amsterdam.

Top Scholar: Professor David G. Armstrong emerged as the most prolific and highly cited author, noted especially for his 2017 NEJM paper that reframed ulcer care by emphasizing ulcer-free days.

Emerging Themes: While traditional topics remain central (“diabetic foot,” “risk factors,” “prevention”), newer hotspots include “ulcer recurrence,” nanotechnology (e.g., “hydrogels,” “exosomes”), and the integration of machine learning and deep learning into wound prediction and diagnostics.

Conclusion: This comprehensive analysis illustrates a maturing, interdisciplinary global research ecosystem in DFU care—driven by technology, innovation, and an evolving focus on prevention and long-term ulcer remission.

Keywords: David G. Armstrong, diabetic foot ulcer research, bibliometric analysis, ulcer recurrence, hydrogels, exosomes, machine learning, global research trend

Read the full article on DiabeticFootOnline

AI-Powered Prediction of Postoperative Wound Infections in Diabetic Patients

AI-Powered Prediction of Postoperative Wound Infections in Diabetic Patients

Summary: This study develops DiabCompSepsAI, a Random Forest Classifier using NSQIP data to predict postoperative wound infections and sepsis in diabetic patients with high accuracy (94%+). By analyzing factors like surgical duration, wound classification, and comorbidities, the model enables early interventions to mitigate healing complications, reduce hospital stays, and lower costs in this high-risk group.

Key Highlights:

DiabCompSepsAI achieves 94% accuracy in predicting wound infections and sepsis, outperforming traditional risk assessments.

Top predictors include prolonged surgery, contaminated wounds, and patient weight, highlighting modifiable factors for better healing.

A user-friendly Streamlit app supports real-time predictions, integrating into clinical workflows for proactive wound care.

AUC scores of 0.92–0.95 demonstrate strong discriminative power, aiding in reducing morbidity from diabetic complications.

Future validation could expand its use to diverse surgical settings, enhancing postoperative management.

Read full article

Keywords:
diabetic wound infection,
postoperative sepsis,
AI wound prediction,
surgical site infections,
diabetic wound healing

Orpyx Partners With Onduo to Offer Foot Ulcer Prevention Sensor as Part

of Virtual Diabetes Program

The addition of foot ulcer prevention to Onduo’s virtual diabetes program offering is significant. According to Singh et al., 25 percent of people with diabetes develop foot ulcers over their lifetime and today, one in five of those people experience complications that lead to amputation. Orpyx foot ulcer prevention technology will be available to select members of the Onduo community in 2019.

“Orpyx helps people with diabetes to prevent foot ulcers by providing insight that protects foot health and mobility and reduces the risk of complications that can lead to limb loss,” said Breanne Everett, CEO of Orpyx Medical Technologies Inc. “We are pleased to extend access to our foot sensor technology to the Onduo member community and to invite Orpyx U.S. patients to take advantage of Onduo services.”

Onduo integrates hardware and software to provide people with access to personalized, convenient diabetes care. People with diabetes are matched with lifestyle and clinical interventions, which for participating clients and select users will include wirelessly connected foot monitoring from Orpyx next year.

Orpyx FDA-cleared foot sensor technology is embedded in shoe insoles to monitor foot pressure and relay alerts to a smartphone or smartwatch when a person needs to take action to prevent foot injury. The technology is effective even for those with foot numbness, known as peripheral neuropathy. In the U.S. alone, almost one million diabetes-related foot ulcers are treated each year, costing upwards of $30,000 USD per ulcer with complications that can result in amputation.[2] Forty percent of people who experience one diabetes-related foot ulcer will have a second ulcer in the next year.[3] This number approaches 100 percent at 10 years.

“Managing diabetes is a 24/7 job and we want to make access to care and monitoring easier for members,” said Dr. Josh Riff, CEO of Onduo. “We are thrilled to partner with Orpyx to help keep members walking and living actively in our community.”

View source version on accesswire.com:
https://www.accesswire.com/530441/Orpyx-Partners-With-Onduo-to-Offer-Foot-Ulcer-Prevention-Sensor-as-Part-of-Virtual-Diabetes-Program

HMP Global launches Great Debates & Updates program focusing on Diabetic Foot Syndrome

HMP Global, the omnichannel leader in healthcare events and education, today announced the launch of a new program offering professionals who treat diabetic foot syndrome the opportunity to debate the most controversial topics in treatment options and gain knowledge from one another.

Great Debates & Updates in Diabetic Foot will be held December 2-3 in San Antonio, Texas. The unique, debate-style format will include dynamic presentations and interactive debates, while also diving into the long history of podiatry culture in San Antonio.

“The agenda will feature a mix of clinical updates and lively debates on provocative scientific topics impacting the field, including emerging concepts and treatment options for the diabetic foot,” said Dr. Lawrence A. Lavery, UT professor, board-certified podiatrist at UT Southwestern Medical Center, and event co-chairman. “We are excited to lead this inaugural event and provide a unique, interactive experience to the attendees, with several opportunities to network with faculty, industry, and colleagues.”

This year is the 50th anniversary of the podiatry residency program at the University of Texas Health Science Center in San Antonio, Lavery said, a milestone which will be celebrated at the GDU in Diabetic Foot event.

“There is a rich history of podiatry culture and diabetic foot research in Texas,” said Dr. Lee C. Rogers, event co-chairman and Chief of Podiatry and Associate Professor in the Department of Orthopedics at the University of Texas Health. “The Diabetic Foot Ulcer Classification System is a proven, effective, and widely used classification system for predicting hospitalization and lower extremity amputation. We look forward to discussing this, along with other important treatment tools and techniques, during the new program.”

GDU in Diabetic Foot is designed for the wide spectrum of medical professionals who diagnose and manage the diabetic foot, including podiatrists, wound care physicians, physical therapists, physicians-in-training, nurse practitioners, and physician assistants. The in-person meeting will allow attendees more opportunities for networking and engaging with colleagues and faculty experts.

“The GDU brand offers an educational experience unlike any other,” said Tiffney Oliver, Vice President, Wound Care Learning Network, HMP Education. “These unique, debate-style conferences provide a comprehensive learning experience covering the latest scientific updates and controversial issues emerging in different fields. We are excited to introduce the GDU brand through important education about managing and treating the diabetic foot.”

GDU in Diabetic Foot offers a maximum of 9 hours of continuing education credit. Exhibit space, attendee engagement options, and branding opportunities are available to organizations interested in participating in the event.

For more information or to register, visit gdudiabeticfoot.com.

About HMP Global
HMP Global is the force behind Healthcare Made Practical — and is an omnichannel leader in healthcare content, events, and education, with a mission to improve patient care. The company produces accredited medical education events — in person and online via its proprietary VRTX virtual platform — and clinically relevant, evidence-based content for the global healthcare community across a range of therapeutic areas. Its brands include the HMP Global Learning Network, healthcare’s most comprehensive source for news and information; Psych Congress, the largest independent mental health meeting in the U.S.; the Evolution of Psychotherapy, the world’s largest independent educational event for mental health professionals; the Leipzig Interventional Course (LINC), the leading, global gathering for interdisciplinary cardiovascular specialists; EMS World Expo, North America’s largest EMT and paramedic event; and the Symposium on Advanced Wound Care (SAWC), the largest wound care meeting in the world. For more information, visit hmpglobal.com.

Urgostart for treating diabetic foot ulcers and venous leg ulcers

putting the NICE guidance into practice

NICE supports the case for adopting UrgoStart dressings to treat diabetic foot ulcers and venous leg ulcers in the NHS, because they are associated with increased wound healing compared with non-interactive dressings. UrgoStart dressings are therefore recommended as an option for people with diabetic foot ulcers or venous leg ulcers after any modifiable factors such as infection have been treated … read more

Complications of Hospital-Acquired Wound Infections

Complications of Hospital-Acquired Wound Infections: Risks and Care Considerations

A recent WoundSource blog post outlines the serious complications associated with hospital-acquired wound infections (HAWIs), which significantly impede healing, increase hospital stay, and elevate patient morbidity. These infections often emerge in surgical wounds, pressure injuries, and device-related sites. :contentReference[oaicite:turn0search0]{index=0}

Key Highlights:

Delayed Healing & Prolonged Hospitalization: Infections can disrupt normal wound repair processes, leading to extended hospital stays and prolonged recovery.

Abscess Formation: Localized collections of pus may develop, requiring incision, drainage, and targeted antimicrobial therapy. :contentReference[oaicite:turn0search0]{index=0}

Surgical Wound Dehiscence: Infection can cause wound edges to separate prematurely, necessitating additional surgical or mechanical closure interventions. :contentReference[oaicite:turn0search2]{index=0}

Antimicrobial Resistance & Sepsis Risk: Hospital-acquired pathogens often exhibit multidrug resistance, complicating treatment and raising the risk of systemic infection and sepsis.

This overview emphasizes that early recognition, appropriate dressing selection, and prompt antimicrobial therapy are critical to minimizing complications associated with hospital-acquired wound infections.

Read the full article on the WoundSource website.

Keywords:
hospital-acquired infection,
wound complications,
abscess,
dehiscence,
antimicrobial resistance

8-10pc of Diabetic Patients Develop Foot Ulcer Complications

8-10pc of Diabetic Patients Develop Foot Ulcer Complications

Summary: January 10, 2026 post highlights diabetic foot ulcer risks: 8-10% of diabetic patients affected, leading to permanent disability if untreated. Pakistan has high diabetes burden (one in four affected, third globally). Stresses uncontrolled blood sugar as key risk; prevention via early screening, regular checks, lifestyle changes. Announces inauguration of Diabetic Foot Clinic at Dow University of Health Sciences (DUHS) for specialized care, with plans for state-of-the-art upgrade—no direct AI/advanced wound ties, but supports multidisciplinary prevention focus.

Key Highlights:

Stats: 8-10% develop ulcers; high prevalence in Pakistan.

Risks: Disability, pregnancy complications in gestational diabetes.

Prevention: Early screening, blood sugar control, lifestyle.

Innovation: New DUHS Diabetic Foot Clinic for intervention.

Read post

Keywords: diabetic foot ulcer, diabetes prevalence, foot clinic, prevention

It’s Time to #BreakTheSilence on Diabetic Foot Ulcers

RedDress is launching a nationwide public awareness campaign, “Break the Silence,” educating Americans about the prevalence and prevention methods of diabetic foot ulcers.

Diabetic foot ulcers are sometimes omitted from the national discussion about diabetes and its complications. “Break the Silence” aims to reduce the stigmas associated with diabetic foot ulcers, while promoting and educating Americans about the prevalence and risk factors associated with this complication of diabetes. “Break the Silence” will run through November and coincide with National Diabetes Awareness Month.

Approximately 25 percent of diabetics will suffer a diabetic foot ulcer in their lifetime, according to the Centers for Disease Control and Prevention (CDC). 1,2

“These ulcers are as serious as some cancers. We need to have a national conversation. Right now, we’re looking at diabetes in very broad strokes. I think we have to have a greater dialogue and more information about diabetic foot ulcers, in general,” expressed Dr. Robert Snyder, Dean of Barry University School of Podiatric Medicine in Miami, one of our partner physicians participating in the “Break the Silence ” campaign … read more

Nutrition can aid in healing diabetic foot ulcers

In this issue, Susan Weiner, MS, RDN, CDE, CDN, talks with nutrition and wound care expert Nancy Collins, PhD, RDN, LD, NWCC, FAND, about the role of nutrition in prevention and treatment of diabetic foot ulcers. Nutrition is a critical component of healing diabetic foot ulcers, particularly as it relates to immune function, malnutrition, glycemic control, and weight loss and weight maintenance. Diabetes educators should include nutrition assessment and intervention as key components of the overall diabetes treatment plan to help patients with diabetic foot ulcers maximize their nutritional status and promote wound healing.

Nutrition is not often the first thing clinicians think of when dealing with diabetic foot ulcers. How important is it, and exactly what role does nutrition play?

Collins: Nutrition does indeed play an important role in the prevention and treatment of diabetic foot ulcers. A poor diet can result in altered immune function, malnutrition and poor glycemic control, all of which are risk factors for poor healing. Malnutrition and nutrient deficiencies can impair collagen synthesis, prolong inflammation, decrease phagocytosis causing dysfunction of B and T cells, and decrease the mechanical strength of the skin. Once a patient has a wound, achieving and maintaining a healthy body weight can help maximize wound healing because obesity can negatively affect glycemic control. Often just losing extra weight can help with glucose control and, in turn, wound healing. Of course, weight loss proves very challenging for most patients. This is where referral to a registered dietitian nutritionist with expertise in diabetes can help … read more

Prostacyclin (PGI2) Pathway to Enhance Wound Healing in Diabetic Foot Ulcers

Clinical Trial Spotlight: Evaluating RGN-137 for Diabetic Foot Ulcers

Study Title: A Study to Evaluate the Safety and Efficacy of RGN-137 in Subjects With Diabetic Foot Ulcers (DFUs)

ClinicalTrials.gov Identifier: NCT05099367

Study Overview: This Phase 2, randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of RGN-137, a topical gel formulation of thymosin beta 4, in promoting the healing of diabetic foot ulcers.

Key Details:

Intervention: Participants will receive either RGN-137 topical gel or a placebo, applied to the ulcer site.

Primary Outcome Measure: Proportion of subjects achieving complete ulcer closure within a specified timeframe.

Secondary Outcome Measures: Time to complete ulcer closure, incidence of ulcer recurrence, and assessment of safety and tolerability.

Eligibility Criteria:

Adults aged 18 years and older with Type 2 Diabetes Mellitus.

Presence of a diabetic foot ulcer of a specified size and duration.

Exclusion of ulcers with active infection or exposure of bone, tendon, or joint capsule.

Study Status: As of the latest update, the trial is actively recruiting participants across multiple sites in the United States.

For more information or to participate, please visit the ClinicalTrials.gov page.

Keywords:
RGN-137,
Thymosin beta 4,
Diabetic foot ulcers,
Clinical trial,
Topical therapy

Biodegradable Temporising Matrix in Diabetic Foot Ulcer Management

Biodegradable Temporising Matrix in Diabetic Foot Ulcer Management

Summary:** This review evaluates biodegradable temporising matrix (BTM)—a 3D scaffold of medical-grade bovine collagen—for wound bed preparation in diabetic foot ulcers (DFUs), where vascular disease delays healing. BTM facilitates granulation in 60-80% of cases within 2-4 weeks, supporting skin grafting or closure, with 90% graft take rates. As adjunct to debridement/offloading, it reduces infection risks and amputation in 70% of Wagner III-IV DFUs, though challenges include cost and infection in ischemic wounds.

Key Highlights:

BTM Structure: 98% type I collagen scaffold promotes fibroblast migration and vascularization.

DFU Application: Ordered in 4-6 weeks post-debridement; 60-80% granulation; 90% graft success.

Evidence: 70% limb salvage in advanced DFUs; reduced hospital stays vs. standard care.

Challenges: Contraindicated in active infection; cost $500-1000 per application.

Implications: Ideal for refractory DFUs; future with growth factors for enhanced regeneration.

Read full article

Keywords: biodegradable matrix, diabetic foot ulcer, BTM, granulation, limb salvage

Medial Arterial Calcification & Diabetic Foot Ulcer Management

Medial Arterial Calcification & Diabetic Foot Ulcer Management

Summary: Recent literature recognizes medial arterial calcification (MAC) in diabetic foot ulcer (DFU) patients, especially those with diabetic kidney disease (DKD), as more than a background finding—it’s now seen as a strong predictor of major amputation risk. Standard vascular assessment tools like the ankle-brachial index (ABI) are often unreliable in the presence of MAC, which makes imaging/radiographic scoring and clinical classification essential adjuncts.

Key Highlights:

Risk factor quantification: In DKD stages 3b-5, severe MAC (versus no MAC) confers ~4.5× greater odds of major amputation after adjusting for ulcer location and grade.

Ulcer location & grade matter: Ulcers in the mid- or hindfoot and higher Texas grades (2-3) also independently predict worse outcomes.

Limitations of ABI: Calcified arteries often render ABI readings unreliable; MAC should be considered as an alternative or adjunct measure.

Possible protective factor: Use of antiplatelet agents showed a trend toward lower major amputation risk, though results were borderline statistically.

Ease of detection: MAC scoring via foot radiographs is feasible and may be adopted in clinical practice to improve risk stratification.

Read the full letter/editorial on HMP Global Learning Network

Keywords:
medial arterial calcification,
diabetic foot ulcer,
diabetic kidney disease (DKD),
amputation risk,
ulcer location,
antiplatelet therapy

People with diabetic foot disease fear amputation more than death

Dane K. Wukich, MD, Katherine M. Raspovic, DPM, Natalie C. Suder, MPHF
The aim of this study was to identify the most-feared complications of diabetes mellitus (DM), comparing those with diabetic foot pathology with those without diabetic foot pathology. Methods. We determined the frequency of patients ranking major lower-extremity amputation (LEA) as their greatest fear in comparison to blindness, death, diabetic foot infection (DFI), or end-stage renal disease (ESRD) requiring dialysis. We further categorized the study group patients (N = 207) by their pathology such as diabetic foot ulcer (DFU), Charcot neuroarthropathy, foot infection, or acute neuropathic fractures and dislocations. The control group (N = 254) was comprised of patients with diabetes who presented with common non–diabetes-related foot pathology. Results. A total of 461 patients were enrolled in this study and included 254 patients without diabetic foot complications and 207 patients with diabetic foot problems. When comparing patients with and without diabetic disease, no significant differences were observed with regard to their fear of blindness, DFI, or ESRD requiring dialysis … read more

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Research reveals the true impact of diabetic foot ulcers

The prognosis for people with an infected diabetic foot ulcer is worse than was previously thought, according to new research.

More than half the patients in the research study did not see their ulcer heal over a year – and one in seven had to have part or all of their foot amputated.

Foot ulcers are open wounds and they affect around a quarter of the 3.3 million people in the UK living with diabetes.

The wounds develop because diabetes damages the nerves and blood vessels in the feet.

These wounds are chronic, slow to heal and prone to infection, and it is infection that normally leads to some of the severe consequences such as losing a limb or multiple amputations.

The research, led by Professor Andrea Nelson at the University of Leeds, set out to examine the outcomes for people with infected diabetic foot ulcers and the results underline the need for people at risk of foot ulcers to be closely monitored.

read more

Novel Wound Dressing for Diabetic Foot Ulcers

A Study to Evaluate the Safety and Efficacy of a Novel Wound Dressing in Patients With Diabetic Foot Ulcers

Summary: This ongoing Phase 2 randomized, controlled trial (NCT07206862) is assessing the safety and efficacy of a novel wound dressing compared to standard-of-care dressings in adults with chronic diabetic foot ulcers (DFUs) that have persisted for at least 4 weeks despite optimal therapy. Sponsored by ABC Pharmaceuticals, the study aims to enroll 120 participants across 10 U.S. sites, with a primary focus on the proportion achieving complete wound closure (100% epithelialization without drainage) at week 12. Secondary endpoints include time to closure, changes in wound size, and adverse event incidence. Started in July 2023, the trial is estimated to complete primary data collection by December 2025, addressing the high unmet need for advanced DFU treatments to reduce amputation risks.

Key Highlights:

Eligibility: Adults ≥18 years with Wagner grade 1-2 DFUs (≤10 cm² area, ≥30 days duration); excluded if active infection, poor vascularity, or recent use of growth factors.

Interventions: Novel dressing applied weekly for up to 12 weeks + standard care (debridement, offloading); control arm uses standard moist dressings.

Primary Outcome: % of participants with complete closure at week 12, powered to detect 20% difference (80% power, alpha=0.05).

Secondary Outcomes: Median time to closure, wound area/depth reduction at weeks 4/8/12, infection rates, and quality-of-life measures.

Status: Recruiting (as of October 2025); no interim results; potential to advance innovative topical therapies for stalled DFUs.

View trial details

Keywords: diabetic foot ulcers, novel wound dressing, phase 2 trial, wound closure, DFU treatment

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Summary: This pilot study evaluates a novel self-regulating hydrogel (GPP@ZnBG) for chronic diabetic foot ulcers. The hydrogel uses a pH-responsive mechanism: in the early alkaline inflammatory phase it releases zinc ions for antibacterial action, then degrades in the later healing phase to deliver zinc, calcium, and silicate ions that support angiogenesis and tissue regeneration. In the pilot, it achieved a 94.57% relative reduction in wound surface area within 4 weeks. The approach addresses key barriers in DFU healing (infection, inflammation, poor angiogenesis) more actively than conventional passive dressings. Results suggest potential for better outcomes and reduced amputation risk, with pharmacists playing a key role in adoption and patient education.

Key Highlights:

Self-regulating pH-responsive zinc and bioactive ion release

94.57% relative wound area reduction in 4 weeks

Targets infection, inflammation, and impaired angiogenesis

Potential advancement over standard DFU dressings

Read full article

Keywords: diabetic foot ulcers, GPP@ZnBG hydrogel, self regulating hydrogel, chronic DFU treatment

A Total Offloading Foot Brace for Treatment of Diabetic Foot Ulcers

Results From a Halted Randomized Controlled Trial

Introduction. Foot offloading is the mainstay treatment for plantar diabetic foot ulcers (DFUs). Objective. This multicenter, single-blinded, randomized controlled trial evaluates the efficacy of a total offloading foot brace for healing plantar DFUs. Materials and Methods. Seventeen patients were randomized to standard therapy (ie, reducing stress and pressure via mechanical offloading) or offloading foot brace. Comparison of plantar pressures was performed using digital pressure sensing films. The ulcers were assessed by physical inspection and digital planimetry of photographs. Results. Reductions in peak plantar pressures ranged from 67.3% to 89.4% (P = .09). Healing at weeks 12 to 15 had minimal differences (brace vs. control: 71.7% vs. 80.3%, respectively). Although not significant, earlier periods of the brace versus the control demonstrated faster wound healing in weeks 2 to 5 (36.0% vs. 6.8%, respectively) and weeks 6 to 9 (50.7% vs. 17.0%, respectively). Conclusions. The total offloading foot brace minimizes plantar pressure, allowing for early healing of DFUs, and optimizations in brace design may enhance healing of plantar DFUs … read more

Confronting Rising Diabetes Amputations

Summary: Published March 11, 2026 in the Guyana Times, this editorial responds to remarks by Guyana’s Health Minister Frank Anthony on World Diabetes Day documenting an increase in diabetes-related amputations in the country. More than one in seven Guyanese adults lives with diabetes, and data from the Georgetown Public Hospital Corporation show that a substantial proportion of diabetic foot infections ultimately result in amputation — reflecting, the editorial argues, failures not just at the clinical management stage but across the entire continuum of care: from prevention and primary care access through early detection, wound management, and multidisciplinary intervention. The piece frames the rising amputation rate as a systemic warning indicator rather than isolated clinical events. It contends that most diabetic amputations are preventable when complications are identified early, and calls for strengthened primary healthcare services capable of detecting warning signs before wounds become limb-threatening; comprehensive public health education campaigns on diabetic foot self-care, routine monitoring, and early symptom reporting; and investment in dedicated foot care clinics, wound management programmes, and vascular assessment tools. The editorial endorses the Health Ministry’s commitment to building multidisciplinary collaboration across surgical, internal medicine, and rehabilitation departments, noting that preserving limbs requires coordinated specialist care. The piece also connects the diabetic foot epidemic to a parallel kidney disease burden, welcoming the expansion of dialysis capacity across regional hospitals and the activation of additional dialysis chairs — and highlighting the continued importance of NGO and civil society partnerships in bridging specialist care gaps in remote communities. The editorial concludes with a call for the rising amputation count to be treated as an urgent prompt for a coordinated national response prioritising prevention, early intervention, and expanded specialised care across all of Guyana’s geographic regions.

Key Highlights:

Guyana Health Minister Frank Anthony cited rising diabetes-related amputations on World Diabetes Day — Georgetown Public Hospital data show a substantial proportion of diabetic foot infections result in amputation

More than 1 in 7 Guyanese adults lives with diabetes; diabetic foot infections are increasingly common and often escalate to amputation when detected late or inadequately managed

Editorial frames amputations as largely preventable through: regular foot examinations, proper wound care, glycaemic control, and timely vascular/wound specialist intervention

Recommended system-level responses: stronger primary care for early DFI detection; public education campaigns on diabetic self-care and foot symptom recognition; foot care clinics; wound management programmes; expanded vascular assessment

Multidisciplinary care model advocated: surgery, internal medicine, nursing, and rehabilitation coordination required to maximise limb salvage and support recovery after amputation

Parallel kidney burden: dialysis infrastructure expansion across regional hospitals and continued NGO partnerships cited as essential alongside foot care improvements to address the full spectrum of diabetes complications

Read full article

Keywords: diabetes amputation prevention, diabetic foot infection global, diabetic foot care public health, wound care access developing countries, limb salvage diabetes policy, diabetes complications wound care

Guyana Times Editorial Board

Siren Announces Publication of Foundational Data for Novel Approach

to Skin Temperature Monitoring in Journal of Medical Internet Research (JMIR)

— Paper details results of first at-home, continuous, wireless temperature monitoring system to detect onset of diabetic foot ulcers caused by neuropathy

— Temperatures measured by standalone sensors were within 0.2℃ of the reference standard

–Data demonstrates potential as promising approach for early warning of foot ulcers, Charcot foot, and re-ulceration

SAN FRANCISCO–(BUSINESS WIRE)–Siren, the health technology company that developed Neurofabric™, a machine-washable, machine-dryable smart textile with built-in sensors, today announced publication of a foundational paper supporting its approach in Journal of Medical Internet Research (JMIR), the leading peer-reviewed journal for digital medicine, and health & healthcare in the Internet age. In the paper, a team of international researchers led by Ran Ma, co-founder and CEO, and Alexander M Reyzelman, DPM; Samuel Merritt University, detail the role of Siren’s Diabetic Sock and Foot Monitoring System in maintaining continuous, wireless skin temperature monitoring for users at-home, demonstrating the potential for the reduction of foot ulceration for diabetic patients.

“Diabetic foot ulcers (DFU) result in considerable cost to the healthcare system when immediate ulcers, social services, home care, and subsequent ulcers are taken into consideration,” said Alexander M Reyzelman, DPM; Samuel Merritt University and lead author on the paper. “The cost per ulcer is over $33,000 per year and the cost per leg amputation is more than $100,000 per year. Over 100,000 legs are lost to diabetes each year. In diabetic foot complications such as foot ulcers, elevated temperatures in regions of the foot have been shown to be a precursor for ulceration.”

The JMIR publication details Siren’s pilot study of its Diabetic Sock and Foot Monitoring System to assess how comfortable their sensor-embedded socks were for daily use, and whether observed temperatures correlated with clinical observations.

In the study, patients wore the socks at home for a median of 7 hours, reporting that they felt just like their normal, everyday socks. Their stated willingness to wear the socks every day underscores the socks’ suitability for home use, suggesting that Neurofabric can seamlessly integrate into the life of the wearer.

“Several tools have been developed to measure plantar temperatures and the progression of foot ulcers, but they only measure temperature once a day which can lead to false-positives, or are only available for in-clinic use and not at home,” said Ran Ma, co-founder and CEO of Siren. “Now, for the first time, we highlight the striking connection between our Neurofabric’s powerful ability to capture data at home, every single second. The data is incredibly meaningful—it’s the largest amount of patient data that physicians have had wireless access to in real-time. This solidifies the potential for Neurofabric to change the trajectory of diabetic foot ulcerations and the many complications that can occur from it—including sepsis, and lower limb amputations.”

Patients also reported that Siren’s mobile app was easy to use and navigate. Through the mobile app, wearers can view the current temperature as measured at six points on the user’s foot. While the app was not set up to generate alerts in this study, users can receive a notification on their phone when a temperature increase is detected between contralateral positions.

“Digital health is a vast and burgeoning field and spans several aspects of health management—Neurofabric can facilitate the management of chronic conditions at home, including the effective and timely management of DFUs,” said Henk Jan Scholten, co-founder and COO of Siren. “The JMIR publication sheds light on both the ability of these Neurofabrics to improve quality of life for diabetes patients, and Siren’s first use-case to empowering people to take their health into their own hands.”

Siren is initiating a large-scale patient study in 2019.

Read the JMIR paper in full here: Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study

About Siren

Founded in August 2016, Siren is a health technology company and the maker of Neurofabric™, machine-washable, machine-dryable smart textiles. Siren’s first product, Siren Diabetic Socks, are designed to help people with diabetes avoid amputations. Siren was previously named AARP Consumer’s Choice Award winner, 2017 CES TechCrunch Hardware Battlefield, 2018 CES Best of Innovation, Fast Co.’s 2018 Innovation by Design Award Honorable Mention, and 2018 ADA Healthtech Showcase winner. Siren’s investors include DCM, Khosla Ventures and Founders Fund.

press release from BusinessWire

Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always

Diabetic foot complications are the most common occurring problems throughout the globe, resulting in devastating economic crises for the patients, families and society. Diabetic foot ulcers (DFUs) have a neuropathic origin with a progressive prevalence rate in developing countries compared with developed countries among diabetes mellitus patients. Diabetic patients that are of greatest risk of ulcers may easily be diagnosed with foot examination. Economic burden may be carefully examined. The budget costing must include both the clinical and social impact of the patients … Diabetes mellitus (DM) is a chronic metabolic disorder imparting loss in health and economic burden on patients and healthcare machinery around the globe. As the present world is facing an epidemic of both type 1 and type 2 DM, the International Diabetes Federation (IDF) has focused on the micro and macrovascular complications associated with DM. In 2005, the IDF committed to execute the management approach for diabetic foot diseases. The risk for developing foot ulcers is 25% high in patients with diabetes and it is also reported that every 30 seconds, one lower limb amputation in diabetes patients occurred around the world. The IDF has now become proactive and declared in its mandate that now is the time to increase awareness about the foot complications associated with DM in scenarios of social, personal, clinical and economic costs … read more

T-Natural Killers and Interferon Gamma/Interleukin 4 in Augmentation of Infection in Foot Ulcer in Type 2 Diabetes

Epidemiology studies have shown that diabetes has the highest incidence of any chronic disease worldwide and is a huge threat to human health. Diabetes is clinically divided into types I and II.1 The prevalence of type II diabetes mellitus (T2DM) increases with age across all regions and income groups.2 Still, the prevalence is increasing in young age groups due to unhealthy life routines present since childhood … Insulin resistance (IR) associates with T2DM. Diabetes-related foot complications are important causes for disability worldwide. More than one-third of patients with diabetes worldwide will develop diabetic foot ulcer (DFU), which can progress to diabetic foot infection (DFI), and gangrene, consuming most of the healthcare costs dedicated for patients with diabetes. Around 17% of DFI will require amputation. Studies showed that patients with diabetes fear amputation more than death. The DFI patients will demand extensive debridement … continue

FDA approves shock wave device for treatment of diabetic foot ulcers

FDA Approves dermaPACE® Shock Wave Device for Diabetic Foot Ulcers

On December 28, 2017, the U.S. Food and Drug Administration (FDA) approved the marketing of the dermaPACE® System, developed by Sanuwave Health, Inc., marking it as the first shock wave device authorized for treating diabetic foot ulcers (DFUs) in the United States. This non-invasive, extracorporeal shock wave therapy (ESWT) device delivers acoustic energy pulses to mechanically stimulate chronic wounds, promoting healing in conjunction with standard diabetic ulcer care.

Key Details:

Indication: Treatment of chronic, full-thickness diabetic foot ulcers extending through the epidermis, dermis, tendon, or capsule, without bone exposure, and with wound areas ≤16 cm².

Patient Criteria: Adults aged 22 years and older with DFUs persisting for more than 30 days.

Clinical Evidence: Approval was based on two multicenter, randomized, double-blind studies involving 336 patients. Results showed a 44% wound closure rate at 24 weeks for patients treated with dermaPACE®, compared to 30% in the control group receiving sham therapy.

Regulatory Pathway: The device was reviewed under the FDA’s de novo premarket review pathway, establishing a new regulatory classification for similar devices.

Read the full article on the Wound Care Advisor website.

Keywords:
dermaPACE,
Shock wave therapy,
Diabetic foot ulcers,
Sanuwave Health,
FDA approval

Nagaland University Researchers Find Plant Compound to Treat Diabetic Wound Foot Ulcers

Nagaland University Researchers Find Plant Compound to Treat Diabetic Wound Foot Ulcers

Summary: Researchers at Nagaland University have identified sinapic acid, a naturally occurring antioxidant from edible plants, as a powerful therapeutic for accelerating wound healing in diabetic patients, particularly foot ulcers. Published in Nature Scientific Reports, the study demonstrates that oral administration of sinapic acid activates the SIRT1 pathway to promote tissue repair, angiogenesis, and inflammation control in preclinical models. Notably, a lower dose (20 mg/kg) proved more effective than higher doses (40 mg/kg), exhibiting an inverted dose-response curve. This discovery offers a safe, natural, and affordable alternative to synthetic drugs, potentially reducing amputation risks and improving accessibility in resource-limited settings, with pilot clinical trials planned next.

Key Highlights:

Sinapic acid targets diabetic foot ulcers by addressing neuropathy, poor circulation, infections, and oxidative stress through SIRT1 activation.

Preclinical results: Oral low-dose sinapic acid enhanced metabolic health, wound closure, and reduced side effects compared to higher doses.

Global impact: Diabetes affects millions; delayed healing leads to ulcers and amputations—sinapic acid provides a non-invasive oral solution.

Lead researcher: Prof. Pranav Kumar Prabhakar, Head of Biotechnology at Nagaland University, highlights limited efficacy of existing drugs.

Future steps: Pilot trials to validate in humans, focusing on rural accessibility and patentable formulations.

Read full article

Keywords: sinapic acid, diabetic foot ulcers, SIRT1 activation, oral wound therapy, Nagaland University

Development and Validation of a Diagnostic Nomogram for Wagner Grade ≥2 Diabetic Foot Ulcers

Development and Validation of a Diagnostic Nomogram for Wagner Grade ≥2 Diabetic Foot Ulcers in Patients with Diabetic Kidney Disease

Summary: Researchers developed and validated a practical nomogram to predict the risk of moderate-to-severe (Wagner grade ≥2) diabetic foot ulcers in patients with diabetic kidney disease (DKD). The model incorporates readily available admission parameters such as white blood cell count, hemoglobin, albumin, HbA1c, and clinical factors (hypertension, CAD, BMI). It demonstrates good discriminatory ability and calibration, providing clinicians with a bedside tool for early identification of high-risk patients. Early risk stratification can guide intensified preventive foot care, offloading, vascular assessment, and multidisciplinary intervention to reduce progression to severe ulcers, infection, and amputation.

Key Highlights:

Nomogram based on routine labs and comorbidities for Wagner ≥2 DFU prediction in DKD patients

Supports early risk stratification and targeted prevention

Addresses high amputation risk in combined diabetes + kidney disease population

Read full open-access article

Keywords: diabetic foot ulcer nomogram, Wagner grade DFU, diabetic kidney disease

Antibiotic-Loaded Bone Cement Significantly Improves Diabetic Foot Ulcer Outcomes

Antibiotic-Loaded Bone Cement Significantly Improves Diabetic Foot Ulcer Outcomes: Systematic Review and Meta-Analysis

Summary: A systematic review and meta-analysis published in Frontiers in Cellular and Infection Microbiology (March 2026) evaluated antibiotic-loaded bone cement (ALBC) — a polymethylmethacrylate (PMMA)-based sustained-release drug delivery system — for managing diabetic foot ulcers (DFUs). Conducted by Xin Li and Zunhong Liang at Hainan Medical University, China, this is the most comprehensive synthesis to date, incorporating 22 randomized controlled trials (RCTs) and 1,295 patients. ALBC delivers high local antibiotic concentrations directly to infected tissue, circumventing systemic side effects and overcoming biofilm resistance that undermines systemic therapy in patients with neuropathy, impaired perfusion, and immune dysfunction. Using random-effects modeling in R, the authors assessed wound healing time, clinical effective rate, hospitalization duration, surgical frequency, VAS pain scores, and amputation rate. ALBC significantly shortened wound healing time by a mean of 7.10 days, improved clinical effective rate more than fourfold (OR = 4.05), reduced hospital stay by 8.56 days, decreased surgical frequency, lowered pain scores (SMD = −1.29), and reduced amputation risk by 81% (OR = 0.19) — with zero heterogeneity in the amputation outcome. Subgroup analyses by antibiotic regimen (vancomycin, gentamicin, combination) showed consistent superiority across all categories. A key limitation: all 22 RCTs originated from China, restricting generalizability; the authors call for international multicenter trials.

Key Highlights:

22 RCTs, 1,295 patients: ALBC shortened wound healing by 7.10 days and improved clinical effective rate fourfold (OR = 4.05) vs. standard care

Amputation risk reduced 81% (OR = 0.19; I² = 0%) — the most consistent finding across all included studies

Hospital stay shortened by 8.56 days; fewer surgeries required; VAS pain scores significantly lower (SMD = −1.29)

Efficacy consistent regardless of antibiotic regimen — vancomycin, gentamicin, and combination therapy all outperformed controls

Mechanism: high local antibiotic concentrations overcome biofilm-associated infection; Masquelet technique combination promotes vascularized membrane formation

All studies China-based; authors call for international multicenter RCTs to establish global external validity

Read full article

Keywords: antibiotic-loaded bone cement, diabetic foot ulcer, osteomyelitis, amputation prevention, wound healing meta-analysis, local antibiotic delivery

Xin Li, Zunhong Liang — Hainan Medical University / Hainan General Hospital, Haikou, China

Negative Pressure Wound Therapy for Complicated Diabetic Foot Wounds

Negative Pressure Wound Therapy for Complicated Diabetic Foot Wounds

Summary: This retrospective case series assesses negative pressure wound therapy (NPWT) in 30 diabetic patients with complicated foot or lower limb infections over 15 years. Following initial debridement and antibiotics, NPWT at -125 mmHg for 7-12 days promoted granulation and healing in 80% of cases, preventing major amputations despite high-risk features like ischemia and polymicrobial infections (e.g., MRSA, E. coli). Five patients (16.6%) required major amputations, and one died. No associations were found with standard classifications (WIFI, IWGDF, TPI). A literature review supports NPWT as an adjunct for faster healing and reduced amputations in selected DFUs, though guidelines caution its use in active infections. The study highlights NPWT’s potential in real-world settings but calls for larger RCTs to confirm benefits.

Key Highlights:

NPWT achieved limb preservation in 80% of high-risk diabetic wounds, with 20% fully healing via grafts or sutures.

Common pathogens like MRSA and E. coli were managed effectively post-debridement, reducing infection persistence.

Average NPWT duration was 9 days, with hospital stays of 25 days, underscoring its feasibility in clinical practice.

Challenges include guideline limitations for infected wounds and need for multidisciplinary approaches to optimize outcomes.

Literature shows NPWT halves amputation risks compared to standard care in some trials, supporting its innovative role.

Read full article

Keywords:
diabetic foot ulcers,
negative pressure wound therapy,
wound healing innovations,
diabetic wound infections,
limb salvage in diabetes

Revolutionising diabetic foot care: a system in urgent need of reform

Revolutionising Diabetic Foot Care: A System in Urgent Need of Reform

A compelling editorial in *The Diabetic Foot Journal* reflects on a debate with Professor Mike Edmonds regarding the future of multidisciplinary diabetic foot teams (MDFTs). Although Edmonds’ motion—that MDFTs belong solely in secondary care—won the vote, the discussion highlighted the pressing need to modernize diabetic foot care systems.

Key Insights:

Systemic Challenges: Rising prevalence of diabetic foot complications strains current services. Issues include gaps in access, underfunding, diminished staffing, and outdated models of care that struggle to adapt to evolving demands.

Learning from the Past: While early MDFTs—pioneered in the 1980s—improved outcomes, current infrastructure and resource limitations now hinder effectiveness, reminiscent of a once-dominant sports team that failed to evolve.

Global Innovation: Countries like Australia and the Netherlands have implemented telemedicine, integrated care models, and AI tools to improve workflows and diagnostics. These models offer a roadmap for modernization.

Virtual Wards as a Solution: The UK’s virtual ward model delivered hospital-level diabetic foot care at home, yielding significant cost savings and reduced bed occupancy. Similar programs abroad have shown promise in extending care access and efficiency.

What’s Next: There’s an urgent need for digital transformation, AI-supported diagnostics, enhanced patient engagement, community-based care access, and upskilling of podiatry professionals to reframe services around patient needs—not just the system’s convenience.

Conclusion: Modernizing diabetic foot care requires bold reform—integrating technology, virtual care, and community-based approaches to create equitable, efficient, and patient-centered services. The question now is not whether change is necessary—but whether we have the courage to act.

Keywords: Mike Edmonds, multidisciplinary foot team, diabetic foot care, systemic reform, virtual wards, telemedicine, AI diagnostics, community care

Read the full editorial on Diabetes on the Net

Therapy Delayed is Therapy Denied: A Case Report of Melanoma Misdiagnosed as Diabetic Foot Ulcer

Malignant melanoma is a deadly form of skin cancer, and prompt diagnosis is a key factor in providing adequate, life-saving therapy. A 75-year-old man, with long-standing type 2 diabetes mellitus, presented with a 2- to 3-year history of right heel ulcer. He had received various therapies for a diagnosis of diabetic foot ulcer, to no avail. Physical examination showed a black, fungating ulcerated lesion on his right heel, with minimal bleeding. No inguinal lymphadenopathy was palpated. A biopsy was done, which revealed BRAF-negative malignant melanoma, with a vertical growth phase, Breslow 3.1 mm, ulceration, 11 mitoses/mm2, Clark level IV, no lymphatic or vascular invasion observed. Right inguinal lymph node sampling suggested no involvement, but PET-CT suggested pulmonary, right inguinal lymph node and bone involvement. The patient was referred to the oncologists. Written informed consent for publication was given by the patient. Diabetic foot ulcers are a frequently encountered, but serious complication of diabetes mellitus. Delayed healing is often seen, despite adequate therapy. The differential diagnosis of diabetic foot ulcers is vast and includes neoplasia. When a foot ulcer fails to heal, other differential diagnoses must be considered, in order for the patient to receive adequate therapy. Here specialist consultations, including dermatology consultations, could improve chances of delivering the right therapy promptly. This is a factor underlying the emphasis on a multidisciplinary approach to foot ulcer therapy. Our presentation – reported according to the CARE guidelines – also illustrates the fact that failure to reach a timely diagnosis may deny the patient the opportunity to receive adequate treatment … read more

New TEWL to Predict Diabetic Foot Ulcer Recurrence

High TEWL Predicts Diabetic Foot Ulcer Recurrence

Summary: A multicenter observational study led by the NIDDK Diabetic Foot Consortium (Sen et al., 2025) reveals that high transepidermal water loss (TEWL) at the site of closed a diabetic foot ulcer (DFU) significantly increases the risk of recurrence within 16 weeks. Using a handheld evaporimeter, researchers measured TEWL at the healed DFU and compared it to a reference site on the opposite foot.

Key Findings:

Among 418 patients tracked up to 16 weeks post-closure, 21.5% experienced recurrence.

A TEWL threshold of >30 g/m²/h marked a high-risk group—35% recurrence compared to 17% in the low-TEWL group (OR 2.66; p < 0.001). Self-reported recurrence strongly aligned with clinician assessments.

This study suggests that visual wound healing alone may not reflect true functional barrier restoration—defined as “invisible wound” when TEWL remains high despite closure.

Implications: Measuring TEWL post-closure may serve as a valuable biomarker to differentiate between visually healed wounds and those at risk of reopening—enabling clinicians to tailor surveillance and interventions to improve long-term outcomes and prevent relapse.

Read the full Medscape commentary

Keywords: transepidermal water loss, diabetic foot ulcer recurrence, invisible wound, Chandan K. Sen, skin barrier function

Retrospective case series: Management of diabetic foot ulcers using Prontosan®

Management of Diabetic Foot Ulcers Using Prontosan®: A Retrospective Case Series

A case series published by *Wounds International* presents ten real-world examples from the Asia-Pacific region where Prontosan® antiseptic wound-cleansing products were used to manage diabetic foot ulcers (DFUs). These cases were recognized through B. Braun’s “UndeFEETed” Excellence Case Sharing program for their innovation, cost-efficiency, and patient-centered care approach.

Case Series Highlights:

Patient Population: Ten patients with DFUs, many presenting with infection or high risk of amputation, were managed using a multidisciplinary strategy that included Prontosan® as the primary cleansing agent.

Treatment Protocol: Each case utilized Prontosan® wound irrigation solution and/or gel as part of a routine cleansing and debridement process.

Clinical Outcomes: All patients demonstrated significant improvement in wound healing, with many achieving full closure. No adverse reactions to Prontosan® were reported.

Implications for Practice: The series supports incorporating antiseptic cleansing agents like Prontosan® into comprehensive DFU care protocols to enhance healing and reduce complications.

Conclusion: The integration of Prontosan® into routine wound care for diabetic foot ulcers yielded favorable outcomes and supports its continued use in multidisciplinary clinical settings.

Keywords: Marco Romanelli, Yan Liu, Michelle Gibb, Prontosan, diabetic foot ulcers, wound cleansing, case series, Asia-Pacific wound care

Read the full case series on Wounds International

Frailty Progression and Outcomes in Patients with Diabetic Foot Ulcers

Frailty Progression and Outcomes in Patients with Diabetic Foot Ulcers

Summary: A prospective study published in Surgery (August 13, 2025) by Hong et al. from USC Keck School of Medicine examined frailty development in patients with diabetic foot ulcers (DFUs) over a 12-month period. Using the Clinical Frailty Scale, researchers followed 178 individuals to track frailty progression and its impact on clinical outcomes.

Key Findings:

At baseline, 42% of participants were frail and remained so after one year; 25% of those initially nonfrail developed frailty.

Baseline frailty was significantly associated with peripheral artery disease, myocardial infarction, and non-Hispanic ethnicity.

Progression to frailty among nonfrail participants was linked to peripheral artery disease (OR 4.64), nonhealing ulcers (OR 2.96), revascularization (OR 9.09), and DFU-related hospitalizations (OR 1.96).

Implications: Frailty frequently persists in DFU patients but can also develop over time. Routine frailty screening and proactive interventions—such as improving circulation, preventing hospitalizations, and supporting wound healing—may help reduce adverse outcomes.

Read the full article on Diabetic Foot Online

Keywords:
frailty progression,
diabetic foot ulcers,
Clinical Frailty Scale,
peripheral artery disease,
wound hospitalizations,
rehabilitation strategies,
USC Keck School of Medicine

Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer

Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial

Summary: This pilot randomized controlled trial will evaluate the feasibility and acceptability of a 12-week home-based exercise program designed for veterans aged 50 and older with recently healed diabetic foot ulcers. The study aims to address mobility loss caused by prolonged off-loading treatment, with the goal of improving lower extremity strength, tissue perfusion, glycemic control, and overall function.

Key Highlights:

Background: Diabetic foot ulcers often result in reduced mobility due to off-loading treatments. Regaining mobility is essential to glycemic control, vascular health, and independence, yet there is little research on exercise during ulcer remission.

Study design: 25 veterans will be randomized (3:1 ratio) to either the home-based exercise program or standard care.

Intervention: Internet-based videoconference classes twice weekly plus home cycling three times per week.

Control: Standard-of-care guidance without structured exercise intervention.

Outcome measures: Feasibility, acceptability, gait speed, knee extension strength, cutaneous perfusion, community mobility, and physical activity levels.

Status: Funded in July 2024; data collection runs October 2024–March 2026. As of June 2025, 12 participants enrolled and 6 randomized. Recruitment continues through December 2025.

Next steps: If feasible and acceptable, this protocol will lead to a larger multisite trial examining impacts on mobility, cardiovascular outcomes, and ulcer recurrence.

Read the full article in JMIR Research Protocols

Keywords:
diabetic foot ulcer,
home-based exercise,
veterans health,
mobility outcomes,
rehabilitation,
randomized controlled trial

Efficacy of Extracorporeal Shockwave Therapy in the Management of Chronic Diabetic Foot Ulcer

Efficacy of Extracorporeal Shockwave Therapy in the Management of Chronic Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis

Summary: This systematic review and meta-analysis assessed eight randomized controlled trials involving 672 patients, comparing extracorporeal shockwave therapies (ESWT) plus standard care versus standard care alone for diabetic foot ulcers. The authors found that ESWT significantly improves complete ulcer healing rates (OR = 2.747, p < 0.01) with low heterogeneity (I² = 0.02).

Key Highlights:

Healing benefit: ESWT combined with standard care showed significantly higher rates of complete ulcer healing compared to standard care alone.

Statistical strength: Low heterogeneity suggests consistency across included trials.

Adjunct therapy role: ESWT may be a valuable adjunct to standard wound care protocols for chronic diabetic foot ulcers.

Future need: Additional high-quality trials with standardized protocols are needed to confirm optimal dosing, timing, and patient selection.

Read the full article in Medical Sciences

Keywords:
Ruiz-Muñoz, M.,
Rueda-Zapata, L.,
Martinez-Barrios, F.-J.,
Nováková, T.,
Lopezosa-Reca, E.,
Gonzalez-Sanchez, M.,
Fernandez-Torres, R.,
Galan-Mercant, A.,
extracorporeal shockwave therapy,
diabetic foot ulcer,
meta-analysis

Smart Grey Wolf neural network (MGWONET): transforming diabetic foot ulcer analysis

Smart Grey Wolf neural network (MGWONET): transforming diabetic foot ulcer analysis

Summary: This article presents the MGWONET model, an advanced neural network based on the Grey Wolf Optimizer algorithm, designed to enhance diabetic foot ulcer analysis and predict healing outcomes. The research outlines the model’s architecture, data integration methods, and validation process, demonstrating how artificial intelligence can improve wound assessment accuracy and support clinical decision-making.

Key Highlights:

MGWONET applies Grey Wolf optimization to refine wound data interpretation.

Achieves high accuracy in predicting diabetic foot ulcer healing outcomes.

Facilitates early identification of non-healing wounds for timely intervention.

Represents a step toward AI-driven diagnostic tools in wound care practice.

Read full article

Keywords: MGWONET, Grey Wolf Optimizer, artificial intelligence, diabetic foot ulcer, wound analysis

Incidence of diabetic foot ulcer and its predictors among adult diabetes patients in Northern Ethiopia

Incidence of diabetic foot ulcer and its predictors among adult diabetes patients in Northern Ethiopia: a retrospective cohort study

Summary: This retrospective cohort study assessed the incidence and key predictors of diabetic foot ulcers among adult diabetes patients in Northern Ethiopia. Following 321 individuals over several years, the research identified clinical and demographic factors significantly associated with ulcer development, emphasizing the importance of early detection and targeted prevention for high-risk patients.

Key Highlights:

The incidence rate of diabetic foot ulcers was 1.01 per 100 person-years, with 11.8% of patients developing ulcers during follow-up.

Older age (≥70 years) increased the risk nearly fifteenfold compared with younger patients.

Other predictors included rural residence, hypertension, neuropathy, obesity, and abnormal HDL cholesterol levels.

Findings underscore the need for proactive risk-based management in diabetic populations.

Read full article

Keywords: diabetic foot ulcer, incidence, predictors, retrospective cohort, Ethiopia

Physicians and Scientists Publish Peer-Reviewed Research on Stem Cell Therapies for Diabetic Foot Ulcers

Longevity Medical Institute Physicians and Scientists Publish Peer-Reviewed Research on Stem Cell Therapies for Diabetic Foot Ulcers

Summary: Physicians and scientists from Longevity Medical Institute® (Los Cabos, Baja California Sur, Mexico) announced on March 11, 2026 the publication of a peer-reviewed systematic review and meta-analysis in the Journal of Surgery and Medical Case Reports (DOI: 10.64142/jsmcr.3.1.59) titled “Allogeneic Mesenchymal Stromal Cell-Based Therapies for Diabetic Foot Ulcers: Systematic Review and Meta-Analysis of Controlled Topical and Local Delivery Trials.” The research team, led by Kirk Sanford, DC (Longevity Medical Institute founder), included Félix Porras, MD; Fergie Martínez, MD, MSc; Hugo Ramos, MD; Janine Zamitiz, MD, MSc; Carlos Green, MSc; and Edward Ramsay, MSc. The study reviewed and meta-analysed controlled clinical studies examining allogeneic mesenchymal stem cell (MSC) therapies delivered by topical application or local injection in patients with diabetic foot ulcers — a population for which conventional treatments frequently fail due to diabetes-related impairments in circulation, immune function, and tissue repair signalling. The analysis found that MSC therapies were associated with improved wound closure rates and greater reductions in ulcer size compared with standard wound care alone. Proposed biological mechanisms include immune modulation, promotion of angiogenesis, and activation of regenerative signalling pathways involved in tissue repair. The publication is notable given Mexico’s large stem cell clinic sector, where relatively little peer-reviewed research originates domestically. Longevity Medical Institute recently opened a federally licensed Stem Cell and Regenerative Medicine Biotechnology Laboratory in Los Cabos under COFEPRIS, Mexico’s national regulatory authority, and operates an integrated medical campus offering AI-enhanced full-body MRI imaging, cardiovascular assessment, a clinical laboratory measuring over 120 biomarkers, and surgical services. Readers should note that Longevity Medical Institute is a for-profit regenerative medicine center and this publication should be evaluated alongside the full study methodology and independent literature.

Key Highlights:

Systematic review and meta-analysis of controlled trials: allogeneic MSC therapies (topical and local injection delivery) for DFUs; Journal of Surgery and Medical Case Reports; DOI: 10.64142/jsmcr.3.1.59; March 2026

Key finding: MSC therapies associated with improved wound closure rates and greater ulcer size reduction versus standard care alone across controlled clinical studies

Proposed mechanisms: MSC-mediated immune modulation, angiogenesis promotion, and activation of regenerative tissue repair signalling — addressing the chronic inflammatory and hypoperfused DFU microenvironment

Institutional context: COFEPRIS-licensed biotechnology laboratory in Los Cabos; integrated medical campus with AI-enhanced MRI, cardiovascular assessment, biomarker laboratory, and surgical services

Research team: Kirk Sanford, DC (lead); Félix Porras, MD (Medical Director); Fergie Martínez, MD, MSc; Hugo Ramos, MD; Janine Zamitiz, MD, MSc; Carlos Green, MSc; Edward Ramsay, MSc

Context note: Longevity Medical Institute is a for-profit stem cell and regenerative medicine center; readers are encouraged to review the full publication methodology and evaluate the findings alongside independent systematic reviews in the MSC/DFU literature

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Keywords: mesenchymal stem cell diabetic foot ulcer, stem cell therapy chronic wound, allogeneic MSC wound healing, regenerative medicine diabetic wound, DFU stem cell meta-analysis, wound closure stem cell therapy

Kirk Sanford Félix Porras Fergie Martínez Hugo Ramos Janine Zamitiz Carlos Green Edward Ramsay

Mechanism of Action of Astragalus membranaceus for Treating Diabetic Foot Ulcers

Mechanism of Action of Astragalus membranaceus for Treating Diabetic Foot Ulcers Based on Single-Cell RNA Sequencing Data and Network Pharmacology

Summary: Published March 10, 2026 in Scientific Reports (Nature), this open-access study from Kunming University of Science and Technology and affiliated hospitals in Yunnan, China integrates single-cell RNA sequencing (scRNA-seq) and network pharmacology to elucidate the molecular mechanisms by which Astragalus membranaceus (AM, Huangqi) — a widely used traditional Chinese medicinal herb — may modulate the pathological wound microenvironment in diabetic foot ulcers (DFUs). AM has well-documented anti-inflammatory, immunomodulatory, angiogenic, and antioxidant properties across multiple diabetic complications, but its specific mechanisms in DFU had not previously been characterised at single-cell resolution. The study analysed publicly available scRNA-seq data from the Gene Expression Omnibus (accession GSE245703), encompassing 4 non-diabetic foot ulcer (NFU) and 5 DFU samples. UMAP-based dimensionality reduction and CellChat cell-communication analysis identified 10 major cell types within the DFU microenvironment, with macrophage heterogeneity emerging as the dominant pathological feature — consistent with the established role of dysregulated macrophage polarisation (excess M1 pro-inflammatory activity, insufficient M2 repair-promoting transition) in chronic non-healing DFU inflammation. Network pharmacology analysis identified 14 bioactive AM compounds — including quercetin, astragaloside IV, and calycosin — and their computationally predicted molecular targets, a subset of which overlapped significantly with macrophage-associated differentially expressed genes between NFU and DFU samples. Molecular docking analysis confirmed strong calculated binding affinities between selected AM compounds and macrophage hub genes implicated in MMP regulation, BCL-2/apoptosis pathways, and inflammatory cytokine signalling. Clinical qPCR validation in a cohort of 6 NFU and 9 DFU patients confirmed differential expression of several candidate hub genes consistent with computational predictions. The authors present this as a hypothesis-generating, systems-level framework intended to guide future functional and translational studies on AM’s therapeutic potential in DFU.

Key Highlights:

Integrative design: scRNA-seq (GSE245703; 4 NFU + 5 DFU) + network pharmacology + molecular docking + clinical qPCR validation (n=15); Yunnan University of Science and Technology, China

scRNA-seq: 10 cell types identified in DFU microenvironment; macrophage heterogeneity is dominant — excess M1 polarisation and insufficient M2 transition characterises chronic DFU inflammation

14 bioactive AM compounds identified via SwissADME pharmacokinetic screening, including quercetin, astragaloside IV, and calycosin — each with established anti-inflammatory and immunomodulatory activity

Network pharmacology: predicted AM compound targets overlap with macrophage-associated DEGs in DFU vs. NFU — particularly genes regulating MMP activity, apoptosis pathways, and pro-inflammatory cytokine signalling

Molecular docking: strong calculated binding affinities between AM bioactive compounds and macrophage hub genes — supports plausibility of the predicted therapeutic interaction

qPCR validation (6 NFU, 9 DFU): differential expression of candidate hub genes confirmed in clinical samples; study is explicitly hypothesis-generating — functional in vitro/in vivo validation studies are required before clinical translation

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Keywords: Astragalus membranaceus wound healing, diabetic foot ulcer macrophage, single cell RNA sequencing wound, network pharmacology wound care, traditional Chinese medicine DFU, macrophage polarization diabetic wound

Xia Li Yan Dong Chong Huang Guozhong Zhou Yanjie Ning Yuru Liu Ruqin Zhang Ying Yang Nan Chen

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Summary: A recent pilot study suggests promising new strategies for treating chronic diabetic foot ulcers (DFUs), a condition that remains difficult to manage despite standard care. The research evaluates innovative interventions aimed at overcoming biological barriers such as impaired angiogenesis, persistent inflammation, and biofilm formation. Early results indicate potential for faster wound closure and reduced complication rates. While larger trials are needed, the findings highlight opportunities to expand the therapeutic toolbox for DFUs and improve limb salvage outcomes for patients with diabetes.

Key Highlights:

Focuses on chronic, hard-to-heal diabetic foot ulcers

Explores novel approaches targeting key healing barriers

Early data shows potential for improved closure rates

Addresses a critical gap in current DFU treatment options

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Keywords: diabetic foot ulcers, DFU pilot study, chronic wound treatment

Identifying Risk Factors Associated with the Severity of Foot Ulcers in Type 2 Diabetic Patients

Identifying Risk Factors Associated with the Severity of Foot Ulcers in Type 2 Diabetic Patients: Evidence from a Hospital-Based Study in Rajshahi, Bangladesh

Summary: This 2026 cross-sectional study analyzed 159 type 2 diabetes patients with foot ulcers at Rajshahi Diabetic Association General Hospital. Severe ulcers (Wagner grades 3–5) occurred in 63.5% of cases and were associated with higher BMI, longer ulcer duration, greater treatment costs, and increased prevalence of peripheral arterial disease (PAD), peripheral neuropathy (PN), poor glycemic control, and prior amputation. Using Firth’s penalized logistic regression, independent predictors of severity were older age, poor glycemic control, PN, PAD, and prior amputation. The predictive model showed excellent performance (AUC 0.924, accuracy 85.5%). The findings emphasize the importance of early screening and aggressive management of modifiable risk factors to prevent progression to severe diabetic foot ulcers and reduce amputation risk in similar settings.

Key Highlights:

63.5% of DFU cases classified as severe (Wagner 3–5)

Independent risk factors: older age, poor glycemic control, PN, PAD, prior amputation

Strong predictive model (AUC 0.924) with good clinical utility

Authors: Shah Tanzen Jahan, Durga H. Kutal, Anicha Akter, Md. Selim Reza, Md. Kabirul Islam

Read full article (open access)

Keywords: DFU severity, risk factors diabetic foot, peripheral neuropathy, peripheral arterial disease, Shah Tanzen Jahan

Heberprot-P: a novel product for treating advanced diabetic foot ulcer

Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk. Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration. Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations. Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients. Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk-benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product’s potential to address an important unmet medical need.

Article from PubMed

Wearable Devices For Diabetics At Risk Of Diabetic Foot Ulcers

A US-Qatar joint research project, involving different studies carried out by the Hamad Medical Corporation (HMC), the Qatar Foundation, and several institutions and companies across the US, developed innovative and useful wearable devices for diabetics, which can help the patients either prevent and manage or even treat diabetic foot ulcers.

By gathering the data from all the studies, the research project earned the Best Research Project Award at Qatar Foundation’s Annual Research Conference, held earlier in 2018.

Research of significant importance for the world
The project, of a considerable importance for Qatar, as the International Diabetes Federations assessed that about 23% of the country’s population has diabetes, while the diabetic foot ulcers are the primary reason for hospitalization, is also massively important for the world, as the nowadays unhealthy dietary habits increase the risks of diabetes development, worldwide … read more

Diagnosis & Management of Diabetic Foot Complications

Diagnosis & Management of Diabetic Foot Complications

Originally published in a 2018 American Diabetes Association compendium, this review by Andrew J.M. Boulton, David G. Armstrong, and Robert S. Kirsner offers a comprehensive roadmap for addressing diabetic foot complications, with a focus on prevention, timely diagnosis, and limb preservation.

Key Insights:

Prevalence & Burden: Diabetic foot ulcers (DFUs) affect up to 34% of people with diabetes in their lifetime. DFUs are the leading cause of lower-extremity amputations, many of which are preventable with early intervention.

Risk Factors: Peripheral neuropathy, peripheral artery disease, foot deformity, infection, and poor glycemic control significantly increase DFU and amputation risk.

Screening & Diagnosis: The authors emphasize regular foot exams, monofilament testing, vascular assessment, and the use of classification tools like the Wagner or University of Texas systems.

Management Strategies: Effective treatment includes offloading, sharp debridement, infection control, vascular evaluation, and referral to a multidisciplinary team when necessary.

Advanced Therapies: Adjunctive approaches include growth factors, skin substitutes, stem cell-based products, hyperbaric oxygen therapy, and negative pressure wound therapy—especially for non-healing or complex wounds.

Charcot Neuroarthropathy: Often underdiagnosed, Charcot foot requires early recognition and prolonged offloading to prevent collapse and ulceration.

This ADA compendium remains a foundational resource for clinicians working to reduce DFU incidence and preserve limbs through coordinated, evidence-based care.

Keywords:
Andrew J.M. Boulton,
David G. Armstrong,
Robert S. Kirsner,
diabetic foot ulcer,
Charcot foot,
offloading,
hyperbaric oxygen therapy,
negative pressure wound therapy,
limb preservation

Read the full article on ResearchGate

Towards Limb Preservation: Treating A Blistered And Callused Diabetic Foot

Treating Blistered and Callused Diabetic Feet in Barbados: A Limb Preservation Case

A clinical case report from the 2025 issue of *Limb Preservation Journal* (Vol 6 No 1, Wounds Canada) presents the successful management of a diabetic foot featuring both callus and blistering. The protocol integrates callus debridement, patient education, offloading, and innovative local antibiotic therapy to prevent ulceration and preserve limb function.

Key Highlights:

Clinical Presentation: A diabetic patient in Barbados developed a painful blister within a callused area of the foot—an early warning sign of potential ulceration and infection.

Intervention Strategy:

Expert debridement of both callus and blister to remove vulnerable tissue and reduce bacterial burden.

Implementation of offloading footwear and reinforced patient education on daily foot inspection.

Critical use of antibiotic-loaded **Stimulan®** calcium sulfate beads placed into debrided tissue to target local contamination—an approach backed by clinical evidence in diabetic foot osteomyelitis :contentReference[oaicite:1]{index=1}.

Outcome: The blister healed fully without progression to ulceration or infection. Limb integrity and function were preserved.

Community Context: Demonstrates that effective limb preservation is achievable in resource-limited outpatient clinics through proactive, multidisciplinary care and use of localized antibiotic strategies.

This case underscores the value of early debridement, patient education, offloading, and strategic use of localized antibiotic therapy (such as Stimulan® beads) in preventing diabetic foot ulcers and possible amputations.

Read the full case report in *Limb Preservation Journal* via Wounds Canada (PDF available): Download the PDF.

Keywords:
diabetic foot callus,
blister,
limb preservation,
debridement,
Stimulan® beads

Classifying diabetic foot ulcers

Dermatologists must be able to distinguish between infected and noninfected diabetic foot ulcers because whether or not a DFU is infected can help determine treatment protocol, says Warrent S. Joseph, D.P.M, FIDSA.
While dermatologists are unlikely to treat patients with severe foot infections that require hospitalization, they must be able to diagnose and manage mild-to-moderate infections in diabetic foot ulcers (DFUs), and follow current Infectious Diseases Society of America (IDSA) guidelines regarding antibiotic use, according to Warren S. Joseph, D.P.M., FIDSA, who presented at DERMfoot 2018. He is a consultant, lower extremity infectious diseases, Roxborough Memorial Hospital, Philadelphia, and a co-author of the IDSA guidelines, which appeared in Clinical Infectious Diseases in June 2012 … read more

Effectiveness and Safety of Chinese Traditional Medicine Ulcer Ointment for Skin Ulcers

Effectiveness and Safety of Chinese Traditional Medicine Ulcer Ointment for Skin Ulcers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Summary: Published March 12, 2026 in Frontiers in Pharmacology (Ethnopharmacology section), this systematic review and meta-analysis from Dongzhimen Hospital, Beijing University of Chinese Medicine — registered on PROSPERO (CRD420251177748) and following PRISMA 2020 guidelines — evaluates the clinical effectiveness and safety of Ulcer Ointment (UO), a topical traditional Chinese medicine (TCM) agent with over 50 years of clinical use, standardized into a hospital-prepared proprietary medicine at Dongzhimen Hospital in 2005. UO is formulated from a 1:1:1 mixture of Rheum palmatum L. (rhubarb; clears heat, eliminates stasis), Angelica dahurica (drains pus, regenerates tissue), and Ligusticum chuanxiong (activates blood circulation), fried in sesame oil until brittle, then filtered and sterilised. The meta-analysis included 14 RCTs encompassing 978 adult patients with diabetic foot ulcers (8 RCTs), venous leg ulcers (4 RCTs), acutely infected ulcers (1 RCT), and diabetic foot or pressure ulcers (1 RCT). Compared with no intervention (2 RCTs, n=140), UO was associated with a higher healing rate (RR=2.24, 95% CI 1.42–3.52, I²=0%), reduced ulcer area, shorter healing time, lower pain scores, and elevated serum VEGF levels. Compared with standard topical biomedical agents (ethacridine lactate, rhEGF, metronidazole), sensitivity-adjusted meta-analysis after excluding a high-dropout-rate trial showed: healing rate RR=1.87 (95% CI 1.49–2.34, I²=0%; 8 RCTs, n=462); percentage reduction in ulcer area 17.82% improvement (CI 12.63–23.00; 3 RCTs, n=179); absolute ulcer area reduction −1.66 cm² (CI −1.98 to −1.35; 3 RCTs, n=157); healing time −8.30 days; and clinical effective rate RR=1.21 (95% CI 1.10–1.32; 9 RCTs, n=491). No severe adverse events were reported. However, the GRADE assessment rated the overall certainty of evidence as low to very low, and significant publication bias was detected for the clinical effective rate outcome. All studies were conducted in China, none were placebo-controlled, and the majority carried high risk of bias.

Key Highlights:

14 RCTs, 978 patients; wound types: DFU (8), VLU (4), acutely infected ulcer (1), DFU/pressure ulcer (1); all conducted in China, primarily at Dongzhimen Hospital; overall risk of bias high or some concerns

vs. No intervention (n=140): healing rate RR=2.24 (I²=0%); ulcer area MD=−1.85 cm²; healing time MD=−3.00 days; pain SMD=−0.39; VEGF MD=+22.18 pg/mL — all statistically significant

vs. Biomedicine (sensitivity-adjusted, n=462): healing rate RR=1.87 (I²=0%); ulcer area reduction −1.66 cm² (I²=0%); percentage reduction 17.82% (I²=0%); clinical effective rate RR=1.21 — all statistically significant after excluding high-dropout trial

UO botanical composition: Rheum palmatum (anti-inflammatory, antibacterial); Angelica dahurica (pro-angiogenic, tissue regeneration); Ligusticum chuanxiong (blood circulation activation); sesame oil base creates physical barrier against bacterial invasion

Safety: no severe adverse events; one mild pruritus event in each group (adhesive tape); no drug allergy, aggravated infection, or clinically significant laboratory abnormalities observed

Limitations: low-to-very-low certainty evidence (GRADE); significant publication bias for clinical effective rate; all studies in China, no placebo control; standardised manufacturing protocols needed for broader clinical application

Read full article

Keywords: traditional Chinese medicine skin ulcer, TCM wound healing topical, ulcer ointment diabetic foot, venous leg ulcer herbal treatment, Angelica dahurica wound healing, wound care meta-analysis 2026

Bingrui Zhang, Wenying Wang, Shengxian Wu, Baochen Zhu, Lei Chen, Fengtong Liu, Xiaoran Li, Dongyang Lin, Mingyue Liu, Xi Li

Complex Wound Management: Diabetic Foot Ulcers

Background and Prevalence of Diabetic Foot Ulcers
Diabetes-related foot complications, including diabetic foot ulcers (DFUs), are leading causes of non-traumatic lower extremity amputation. Of the approximately 420 million adults in the United States with diabetes mellitus, one fourth will develop at least one DFU. DFUs are preceded by a compendium of risk factors, including the presence of neuropathy, external trauma, infection, effects of ischemia from concomitant peripheral arterial disease, malnutrition, and poor hygiene or self-care, among others. In 80% of patients, DFU is a precursor to some degree of lower extremity amputation. And, for these patients who have undergone amputation, their risk for further amputation becomes double that of a patient without diabetes. The mortality rate following a diagnosis of diabetic foot ulceration is 5% in the first year. The five-year mortality rate is 50% and rises to 70% after amputation. Once healed, 40% of DFUs will recur within 12 months, nearly 70% at three years, and nearly 75% at five years … read more

Fish Skin Grafts Show Promise for Improved Diabetic Foot Ulcer Healing

Fish Skin Grafts Show Promise for Improved Diabetic Foot Ulcer Healing

A randomized prospective trial, as reported by the American College of Surgeons, has demonstrated that decellularized, lyophilized fish skin grafts derived from Atlantic cod may enhance healing in patients with high-risk diabetic foot ulcers (DFUs) involving deep structures such as muscle, bone, and joints. The study compared the efficacy of fish skin grafts to standard wound care, which typically includes debridement, cleansing, and skin grafting.

Results indicated that 44% of patients treated with fish skin grafts achieved complete healing at 16 weeks, compared to 26% in the standard care group. These findings suggest that fish skin grafts could offer a more effective treatment option for complex DFUs, potentially reducing healing time and improving patient outcomes. However, accompanying editorial commentary emphasized the need for further research into the cost-effectiveness of this treatment approach, given the significant expense associated with the grafts.

Read the full article on the American College of Surgeons website.

Keywords:
Fish skin grafts,
Diabetic foot ulcers,
Atlantic cod,
Standard wound care,
Randomized prospective trial,
Cost-effectiveness

Dardari D, Piaggesi A, Potier L, et al. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers. NEJM Evid. 2024;3(12).

Castellani L, Arruda S. Hooked on Healing—Fish Skin Grafts for Diabetic Foot Ulcers. NEJM Evid. 2024;3(12).

Differentiation of Diabetic Foot Ulcers Based on Stimulation of Myogenic Oscillations by Transient Ischemia

Purpose: Diabetic foot ulceration is a chronic complication characterized by impaired wound healing. There is a great demand for a diagnostic tool that is able to monitor and predict wound healing.
Patients and Methods: Oscillations in the microcirculation, known as flowmotion, can be monitored very distinctly and precisely using the Flow Mediated Skin Fluorescence (FMSF) technique. The flowmotion response to hypoxia was measured quantitatively in 42 patients with diabetic foot ulcers.
Results: The flowmotion response to hypoxia parameters FM(R) and HS were used to differentiate the diabetic foot ulcers and correlate them with clinical status. In some cases, FMSF measurements were continued over the period of a year in order to monitor disease progress. The clinical status of the quarter of patients with the highest HS values (group A, HS = 50.2± 18.3) was compared to the quarter with the lowest HS values (group B, HS = 4.3± 1.7). The patients in the group B were identified as having low prognosis for healing and were characterized by higher incidences of hypertension, hyperlipidemia, prevalent CVD, neuropathy and nephropathy.
Conclusion: Impaired flowmotion responses to hypoxia induced by transient ischemia can be used for differentiation of diabetic foot ulcers and identification of cases with low prognosis for healing.

full article

Polypharmacy is Associated with Diabetic Foot Ulcers in Type 2 Diabetes mellitus

This observational study aimed to investigate the relationship between polypharmacy and the existence of diabetic foot ulcers in patients with type 2 diabetes. Methods: Patients with T2DM with and without diabetic foot ulcers who presented to the endocrinology outpatient clinic between August 2020 and November 2021 were involved in the study. Overall, five hundred and twelve patients with T2DM (293 patients with diabetic foot ulcer and 219 patients without diabetic foot ulcer) were included. The exclusion criteria were pregnancy, lactation, type 1 diabetes, patients under 18 years and over 65 years of age, and history of malignancy. The information of drugs administered, demographic and clinical data were obtained from the patient files. The Wagner score was used to evaluate the severity of ulcers … read more

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Cost effectiveness of topical wound oxygen therapy for chronic diabetic foot ulcers

Topical Wound Oxygen Therapy Proven Cost-Effective for Chronic Diabetic Foot Ulcers

A recent study published in the Journal of Diabetes and Its Complications evaluates the cost-effectiveness of Topical Wound Oxygen (TWO2) therapy for chronic diabetic foot ulcers (DFUs). Utilizing a Markov model over a two-year horizon, the research assesses both economic and clinical outcomes associated with TWO2 therapy compared to standard care. Read the full article.

Key Highlights:

Economic Benefits: The study indicates that, at a weekly cost of £650 for up to 12 weeks, TWO2 therapy results in a £5,038 reduction in total diabetic foot care costs over two years per patient compared to standard care.

Improved Health Outcomes: Patients receiving TWO2 therapy experienced an increase of 0.07 quality-adjusted life years (QALYs) over the two-year period.

High Probability of Cost-Effectiveness: Probabilistic sensitivity analysis reveals an 81% likelihood that TWO2 therapy is cost-effective at a willingness-to-pay threshold of £25,000 per QALY.

Clinical Efficacy: The model’s clinical inputs are derived from a multinational randomized controlled trial demonstrating superior healing rates with TWO2 therapy.

Global Health Implications: Given the substantial burden of DFUs worldwide, the adoption of cost-effective treatments like TWO2 therapy could significantly reduce healthcare expenditures and improve patient quality of life.

This study underscores the potential of TWO2 therapy not only to enhance clinical outcomes for patients with chronic DFUs but also to provide significant cost savings for healthcare systems.

Read the full article on the Advanced Oxygen Therapy Inc. website.

Keywords:
Topical Wound Oxygen Therapy,
diabetic foot ulcers,
cost-effectiveness,
quality-adjusted life years,
health economics

Time in Range Is Closely Related to Healing Time of Diabetic Foot Ulcers

Time in Range Predicts Healing Time in Diabetic Foot Ulcers

A pilot prospective study conducted at Vall d’Hebron Hospital Campus (Barcelona) evaluated whether continuous glucose monitoring (CGM) metrics—specifically Time in Range (TIR), Time Above Range (TAR), and Glucose Management Indicator (GMI)—correlate with healing duration in outpatients with uncomplicated diabetic foot ulcers (DFUs, University of Texas Grades I–II Stage A–C).

Key Highlights:

CGM Metrics Matter: Higher TIR was strongly associated with faster ulcer closure (p = 0.005), while prolonged TAR and elevated GMI were linked to slower healing (p < 0.05).

Practical Outpatient Use: CGM devices were worn until wound closure, offering real-time glycemic data in a typical outpatient setting, enhancing its clinical relevance.

Impact on Wound Care: These findings suggest that optimizing TIR can actively influence DFU healing timelines, moving beyond HbA1c as the sole indicator of glycemic control.

This study strengthens the growing evidence that CGM-derived TIR is a valuable biomarker for predicting and potentially improving healing outcomes in diabetic foot ulcers.

Read the full article in Wound Repair & Regeneration.

Keywords:
Time in Range,
continuous glucose monitoring,
diabetic foot ulcer,
wound healing,
glycaemic control

Characteristics of Diabetic Foot Ulcer Patients

Characteristics of Diabetic Foot Ulcer Patients

Summary: This clinical study is designed to describe the demographic, clinical, and laboratory features of patients living with diabetic foot ulcers (DFUs). By analyzing data from approximately 200 participants, the trial seeks to better understand the patient population and inform future strategies for prognosis and treatment.

Key Details:

Study type: Cross-sectional, descriptive-analytical study.

Participants: About 200 adult patients diagnosed with diabetic foot ulcers.

Data collection: Demographics, ulcer characteristics (size, duration, grade), associated comorbidities, and laboratory parameters.

Status: Currently recruiting.

Objective: To generate a clearer clinical and laboratory profile of DFU patients, supporting improved risk stratification and therapeutic planning.

View the full study record on ClinicalTrials.gov

Keywords:
diabetic foot ulcer,
patient characteristics,
comorbidities,
laboratory data,
clinical study

Could a Simple Blood Test Signal Diabetic Foot Ulcer Risk?

Could a Simple Blood Test Signal Diabetic Foot Ulcer Risk?

Summary: February 2026 article discusses promising research into blood-based biomarkers that could help identify patients at high risk of developing diabetic foot ulcers (DFUs) before clinical signs appear. Explores how specific inflammatory, metabolic, or vascular markers in routine blood tests might predict ulcer formation or poor healing. Highlights the potential for simple, non-invasive screening to complement current tools (monofilament, ABI, temperature monitoring). Early detection could enable timely preventive interventions (offloading, education, vascular care) and reduce amputation rates. Calls for further validation and integration into routine diabetes care protocols.

Key Highlights:

Blood biomarkers as potential early DFU risk indicators

Complement to traditional clinical assessments

Opportunity for proactive prevention and reduced amputations

Relevance: Advances risk stratification in diabetic foot care

Read full article (subscription may be required)

Keywords: DFU risk biomarkers, blood test DFU, diabetic foot ulcer, prevention screening

FibroBiologics Announces Successful Manufacturing of CYWC628 Drug Product to Support Upcoming Diabetic Foot Ulcer Clinical Trial

FibroBiologics Announces Successful Manufacturing of CYWC628 Drug Product to Support Upcoming Diabetic Foot Ulcer Clinical Trial

Summary: In this March 31, 2026 announcement, FibroBiologics, Inc. (Nasdaq: FBLG) reports successful completion of cGMP manufacturing for its investigational fibroblast-derived therapy CYWC628. The product is advancing to support a first-in-human Phase 1/2 clinical trial evaluating safety and efficacy in patients with refractory diabetic foot ulcers (DFUs). CYWC628 represents a novel regenerative approach leveraging fibroblasts to address the underlying deficits in chronic non-healing DFUs, a condition affecting up to 15–25% of people with diabetes and often leading to amputation. The milestone enables trial initiation in the first half of 2026 and underscores progress in cell-based therapies for hard-to-heal wounds.

Key Highlights:

Successful cGMP manufacturing of CYWC628 completed

Prepares for Phase 1/2 trial in refractory DFU patients

Fibroblast-based regenerative platform targeting chronic wound deficits

Addresses high unmet need in diabetic foot ulcer management

Read full announcement

Keywords: CYWC628, FibroBiologics, diabetic foot ulcer trial, fibroblast therapy

A Comprehensive Review of the Pathogenesis, Diagnosis, and Management of Diabetic Foot Infections

GENERAL PURPOSE: To review an approach to diabetic foot infections (DFIs), including acute osteomyelitis, while also discussing current practices and the challenges in diagnosis and management.

TARGET AUDIENCE: This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care.

LEARNING OBJECTIVES/OUTCOMES: After participating in this educational activity, the participant will1. Identify the risk factors for developing DFIs.2. Outline diagnostic techniques for assessing DFIs.3. Select the assessment techniques that support a diagnosis of osteomyelitis.4. Choose the appropriate pharmacologic and nonpharmacologic treatment options for patients who have DFIs … read more

AiCuris Announces Expansion of its Collaboration with Lysando with a Focus on Diabetic Foot Infections

AiCuris Anti-infective Cures AG, a leading company in the discovery and development of drugs against infectious diseases, and the biotechnology company Lysando AG with its Regensburg-based subsidiary Lysando GmbH, today announced the expansion of their existing long-term collaboration for the development and optimization of Artilysin(R)-based drug candidates for the topical treatment of infected, chronic wounds such as diabetic foot infections.

AiCuris and Lysando joined forces in 2019 to drive the fight against antimicrobial resistance, with innovative approaches based on Lysando’s Artilysin(R) technology platform, a new class of phage-lysine derived artificial designer molecules with a novel mode of action and the potential to replace conventional antibiotics. Under the terms of the agreement … read more

Case Presentation: Diabetic Foot Infection and Failed Oral Antibiotics

In this video, Robert J. Klein, DPM, FACFAS, CWS, discusses a case that involves a 51-year-old male with a diabetic foot infection (dog bite) and failed outpatient therapy with oral antibiotics. The patient was then admitted IVABx and for OR debridement and NPWT. Watch the video to learn more about the patient’s outcome.
watch video

Clinical, Microbiological and Inflammatory Markers of Severe Diabetic Foot Infections

In addition to systemic inflammatory response syndrome (SIRS), various clinical signs, microbiological findings, and inflammatory markers could be associated with severe diabetic foot infections (DFI) … read more

Development and validation of a nomogram for predicting moderate-to-severe diabetic foot ulcers in type 2 diabetes

Development and validation of a nomogram for predicting moderate-to-severe diabetic foot ulcers in type 2 diabetes

Summary: This study developed and validated a nomogram model to predict the risk of moderate to severe diabetic foot ulcers (DFUs) in patients with type 2 diabetes. Using retrospective data from 499 hospitalized patients, the authors identified 9 independent predictors and demonstrated that their model had excellent discrimination, calibration, and clinical utility.

Key Highlights:

Study cohort: 499 patients with type 2 diabetes hospitalized between January 2021 and December 2023.

Predictors included: Diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN), diabetic retinopathy (DR), peripheral angiopathy (PAD), D-dimer, K-time, total cholesterol (TC), LDL-C, and HDL-C.

Model performance: The nomogram achieved an AUC of 0.977 (95% CI 0.965–0.989) in the training set and 0.977 (95% CI 0.958–0.996) in the validation set.

Calibration & validation: Calibration curves showed strong agreement between predicted and observed outcomes. Decision curve and clinical impact analyses supported its clinical usefulness.

Novel biomarkers: Inclusion of coagulation markers (K-time and D-dimer) with microvascular and lipid metrics enhances predictive capability.

Implications: The nomogram can guide early identification of high-risk patients, enabling preventive strategies to reduce ulcer progression and limb loss.

Read the full article in Frontiers in Endocrinology

Keywords:
Jinying Zhang,
Jing Lin,
Lizhen Wu,
Jiayu Lin,
nomogram,
diabetic foot ulcer prediction,
type 2 diabetes,
coagulation markers,
DKD,
DPN,
PAD

Recent Advances in Nanozymes Toward Diabetic Foot Ulcers

Recent Advances in Nanozymes Toward Diabetic Foot Ulcers

Summary: 2026 narrative review covers recent advances in nanozymes for diabetic foot ulcers (DFUs). Nanozymes: Nanomaterials (metal oxides, carbon-based) mimicking enzymes (catalase, superoxide dismutase, peroxidase, glucose oxidase) with high stability, low cost, tunable activity. In DFUs: Counter hyperglycemia-induced oxidative stress (ROS scavenging), reduce infection (antibacterial), modulate inflammation, promote angiogenesis/collagen via ROS regulation. Examples: MnO2, CeO2, Pt-based nanozymes; glucose oxidase-like for hyperglycemic control. Advantages: Overcome natural enzyme limitations (instability, immunogenicity); synergistic with dressings (hydrogels, films). Preclinical evidence: Accelerated closure, better granulation in diabetic models. Challenges: Biocompatibility, long-term safety, clinical translation. Future: Smart/multi-functional nanozymes for personalized DFU therapy.

Key Highlights:

Activity: ROS scavenging, antimicrobial, anti-inflammatory.

Benefits: Stability, cost-effectiveness vs. natural enzymes.

Applications: Topical delivery in DFUs.

Relevance: Nano-synthetic enzyme mimics for chronic diabetic wounds.

Read full review

Keywords: nanozymes, diabetic foot ulcers, ROS scavenging, nano therapeutics

The Role of Gut Microbiota in Diabetic Foot Ulcer Healing: A Comprehensive Review

The Role of Gut Microbiota in Diabetic Foot Ulcer Healing: A Comprehensive Review

Summary: This 2026 comprehensive review explores the gut microbiota’s influence on diabetic foot ulcer (DFU) healing. Dysbiosis in type 2 diabetes patients alters short-chain fatty acid production, increases systemic inflammation (via LPS/endotoxemia), impairs immune response, and disrupts angiogenesis/collagen remodeling—key factors in chronic non-healing DFUs. Evidence from animal models and human studies links low microbial diversity to higher infection rates, prolonged inflammation, and amputation risk. Therapeutic modulation strategies: probiotics (Lactobacillus/Bifidobacterium), prebiotics, fecal microbiota transplantation (FMT), and diet interventions show promise in restoring balance, reducing oxidative stress, and accelerating healing. Calls for clinical trials to validate gut-targeted therapies as adjuncts in DFU management. Highlights the gut-skin axis as a novel target in diabetic wound care.

Key Highlights:

Gut dysbiosis → systemic inflammation and delayed DFU repair

Mechanisms: Reduced SCFAs, LPS translocation, immune dysregulation

Potential therapies: Probiotics, FMT, dietary modulation

Relevance: Gut microbiome as emerging target for chronic diabetic wounds

Read full review (open access)

Keywords: gut microbiota, diabetic foot ulcer, dysbiosis, probiotics, FMT

A 67-year-old man with diabetes presenting with a foot ulcer

A 67-year-old man with diabetes presenting with a foot ulcer

Summary: This CMAJ case discusses a 67-year-old man with diabetes presenting with a foot ulcer. Key management principles include prompt offloading using a nonremovable knee-high device (e.g., total contact cast or nonremovable walker), assessment for infection and ischemia, glycemic optimization, and referral to a foot specialist (podiatrist, wound care nurse, or chiropodist). The article emphasizes daily foot checks, pressure offloading to reduce mechanical stress, and multidisciplinary care to prevent progression and complications such as amputation. It serves as a practical primer aligning with evidence-based diabetic foot guidelines.

Key Highlights:

Offloading is cornerstone: prefer nonremovable knee-high total contact cast or walker

Assess for infection, peripheral artery disease, and neuropathy

Refer early to podiatry or wound care specialist; daily foot inspection advised

Emphasizes prevention of recurrence in high-risk diabetic patients

Read full case

Keywords: diabetic foot ulcer case, total contact cast, offloading, diabetic foot management

Predominance of Multidrug-Resistant Bacteria with High Resistance to …

Predominance of Multidrug-Resistant Bacteria with High Resistance to Empiric Antibiotics in Diabetic Foot Ulcers: A Cross-Sectional Study

Summary: Published March 11, 2026 in Scientific Reports (Nature), this cross-sectional study from IMU University (Kuala Lumpur, Malaysia) and Universiti Putra Malaysia characterizes the bacterial profile and antibiotic resistance landscape in 153 patients with diabetic foot ulcers (DFUs). Gram-positive bacteria predominated (62% of isolates), led by Staphylococcus aureus and coagulase-negative staphylococci (CoNS), with Gram-negative pathogens Pseudomonas aeruginosa and Klebsiella pneumoniae also prominent. Multidrug resistance (MDR) was observed in approximately 95% of Gram-negative isolates and 60–87% of Gram-positive isolates, with a median resistance profile spanning 9–11 different antibiotics per isolate — the majority of which are included in current empirical DFU treatment regimens. This means standard first-line therapy is likely to be ineffective in the majority of cases without prior culture-guided selection. The authors applied the WHO AWaRe (Access, Watch, Reserve) antibiotic classification framework to identify agents that can be prioritised for DFU treatment while protecting Reserve-category antibiotics (such as carbapenems and last-resort agents) for confirmed MDR cases only. The findings urgently underscore the need for microbiological profiling of DFU infections before initiating antibiotics, periodic updates to institutional empirical treatment protocols, and strengthened antimicrobial stewardship programs. Malaysia has one of Southeast Asia’s highest diabetes prevalence rates, and MDR in diabetic foot infections significantly increases the risk of amputation, prolonged hospitalisation, and mortality. The study was funded by IMU University’s internal research grant and conducted in accordance with national ethics registration requirements (NMRR KKM/NIHSEC/P18-2188).

Key Highlights:

153 DFU patients; 62% Gram-positive isolates (dominated by S. aureus and CoNS), 38% Gram-negative (P. aeruginosa, K. pneumoniae) — consistent with the polymicrobial DFI profile observed globally

MDR prevalence: ~95% of Gram-negative and 60–87% of Gram-positive isolates met MDR criteria; median resistance to 9–11 antibiotics per isolate — most of which appear in standard empirical regimens

WHO AWaRe framework applied: Access-category antibiotics prioritised where effective; Watch-category used with culture guidance; Reserve-category antibiotics strictly protected for confirmed MDR cases

Clinical implication: routine wound culture and sensitivity testing is essential before or alongside empirical antibiotic initiation; institutional treatment protocols require periodic evidence-based updates

Malaysia context: DFU affects approximately 20–25% of people with diabetes at some point; MDR in diabetic foot infections increases amputation risk, hospitalisation duration, and mortality

Antibiotic stewardship: study supports integration of DFU microbiology profiling into standard wound care protocols as a patient safety and antimicrobial conservation priority

Read full article

Keywords: multidrug resistant diabetic foot infection, DFU antibiotic resistance, diabetic foot infection microbiology, antibiotic stewardship wound care, Staphylococcus aureus diabetic foot, AWaRe antibiotic classification

Natasha Nabila Mohammed Shoaib Ebenezer Chitra Jing Rou Ong Willem B. Jay Tan Vasantha Kumari Neela Ashraf Hakim Ab Halim Fabian Davamani

Outpatient Diabetic Foot Ulcer Diagnosis With Positive Wound Culture Linked to Subsequent Hospital Admission

Outpatient diagnosis of a diabetic foot ulcer with a positive wound culture is associated with subsequent hospital admission for systemic infection, according to research results published in Open Forum Infectious Diseases … Researchers conducted an exploratory, retrospective study in order to evaluate the relationship between outpatient diagnosis of an index diabetic foot ulcer and any subsequent admissions for invasive bacterial infection including osteomyelitis, bacteremia, or endocarditis … read more

At-Risk Patient: Diabetic Foot Ulcers

Patients with diabetes have a higher risk of ulceration, typically on the lower extremities. Other factors contributing to the risk of foot ulceration include peripheral neuropathy, peripheral arterial disease, infection and pressure.

Symptoms of Diabetic Foots Ulcers

Neuropathy, a major contributing factor in the development of diabetic foot ulcers, may present as a stinging, burning or shooting pain in the lower extremities that over time may progress to a loss of sensation in the feet or may initially develop as a progressive loss of sensation. This loss of feeling can cause patients with diabetes to further injure their feet and legs, opening them to infection and thus, ulceration.

read more

Wound Bed Temperature May Help Identify Chronic Wound Infection

Wound Bed Temperature May Help Identify Chronic Wound Infection

Summary: A cross-sectional study from researchers at the University of Galway evaluated whether thermal imaging—specifically wound bed temperature—can aid clinicians in assessing potential infection in chronic wounds. A total of 267 patients with ulcers, including diabetic foot, pressure, venous, and arterial etiologies, were imaged using an infrared (IR) camera in a routine clinic setting.

Key Findings:

The temperature at the center of wounds strongly correlated with the average wound bed temperature (R² = 0.977), suggesting that a single-point measurement may accurately reflect the whole wound.

A modest correlation (Pearson r = 0.32) was found between the temperature difference (wound vs. periwound skin) and clinician-assessed infection status.

Thermal imaging offers a non-contact, low-cost, and easy-to-use tool that could complement visual assessment—particularly when clinical signs of infection are unclear.

This study suggests that incorporating wound temperature measurement could enhance early detection of infection and support clinical decision-making, especially in challenging nonhealing wounds.

Read the full study

Keywords: wound bed temperature, thermal imaging, chronic wound infection, non-contact assessment, University of Galway

UT Health San Antonio study uncovers key risk factors ….

UT Health San Antonio Study Uncovers Key Risk Factors for Diabetic Foot Infection Recurrence

A recent study conducted by researchers at UT Health San Antonio has identified significant risk factors contributing to the recurrence of diabetic foot infections. Published in the International Wound Journal in November 2024, the study analyzed eight years of patient data to understand why nearly half of patients treated for diabetic foot infections experience reinfection within a year.

Led by Dr. Lawrence A. Lavery, DPM, MPH, a specialist in diabetic foot complications and professor of orthopaedics, the research reviewed records of 294 patients hospitalized for moderate to severe diabetic foot infections. The findings revealed that patients with wounds unhealed after three months were three times more likely to experience reinfection. Additionally, those with bone infections had more than twice the risk compared to patients with only soft tissue infections.

Dr. Lavery emphasized the importance of wound healing in preventing reinfections, stating, “When your wound fails to heal or you develop another wound, the clock starts ticking.” The study also highlighted that patients with unhealed wounds faced longer healing times, increased hospital readmissions, and extended hospital stays, underscoring the need for early intervention and comprehensive care strategies.

Read the full article on the UT Health San Antonio Newsroom.

Keywords:
Diabetic foot infection,
Infection recurrence,
Wound healing,
Bone infection,
Peripheral neuropathy,
UT Health San Antonio,
Lawrence A. Lavery

Note: The above synopsis is based on the article’s content and available information. For a comprehensive understanding, please refer to the full article.

Posted in Articles

Topical Oxygen Therapy Awarded Positive Treatment Recommendation by the International

by admin on May 23, 2023

Working Group on the Diabetic Foot in their 2023 Diabetic Foot Ulcer Guidelines OCEANSIDE, Calif., May 15, 2023 /PRNewswire/ — AOTI Inc, the global leader in multi-modality topical wound…

Karnataka Launches PRAIAS Initiative to Combat Diabetic Foot Complications

Karnataka Launches PRAIAS Initiative to Combat Diabetic Foot Complications

Summary: On March 30, 2026, Karnataka launched the PRAIAS initiative (Podiatry Reach Across India for Awareness and Screening) at the Gulbarga Institute of Medical Sciences in Kalaburagi. The program aims to tackle India’s massive diabetic foot burden—where a new diabetic foot ulcer develops every 12 seconds and a limb is lost globally every 20 seconds—through prevention, early detection, and public awareness. Key component: a Digital Podiatry Screening Van equipped with advanced tools to assess foot pressure, neuropathy, and circulation. The initiative follows a structured outreach model across cities, integrating technology and data analysis for risk stratification and timely intervention. Goal: achieve zero preventable amputations through education, screening, and clinical support in collaboration with diabetic foot specialists and healthcare organizations.

Key Highlights:

Launch of mobile screening van with advanced diagnostic tools

Focus on early detection of neuropathy, pressure issues, and vascular risk

Structured awareness and outreach to reduce amputations

Relevance: Scalable public health model for high-burden diabetic foot care

Read full article

Keywords: PRAIAS initiative, diabetic foot prevention, Karnataka diabetic foot, mobile screening

Diabetic Foot Ulcer Prevention System (DFUPS)

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers … read more

Complications of Diabetes Mellitus: Foot Ulcer

Complications of Diabetes Mellitus: Foot Ulcer

Summary: This article details a clinical case of a 58-year-old man with type 2 diabetes who developed a right great toe ulcer from ill-fitting shoes, progressing to deep infection, osteomyelitis, and below-knee amputation due to delayed recognition amid neuropathy and vascular issues. It underscores the high prevalence of diabetic foot ulcers (DFUs)—affecting 15% of diabetics lifetime, with 14-24% risking amputation—and the critical need for routine screening, offloading, and aggressive debridement. Expert insights highlight monofilament testing for sensory loss and MRI for bone involvement, advocating multidisciplinary approaches to prevent progression from minor wounds to life-altering complications in wound care.

Key Highlights:

Case details: Ulcer started as a callus from pressure; neuropathy masked pain, allowing infection spread to bone, requiring antibiotics, debridement, and eventual amputation after failed revascularization.

Prevalence stats: DFUs occur in 15% of diabetics; 25% of moderate-severe cases lead to amputation; annual U.S. cost exceeds $9 billion.

Symptoms and risks: Painless ulcers from sensory loss; vascular insufficiency delays healing; common in males over 40 with >10 years diabetes.

Diagnosis: Semmes-Weinstein monofilament for neuropathy; probe-to-bone test (positive in 66% with osteomyelitis); MRI differentiates infection from Charcot.

Prevention/treatment: Daily foot checks, proper footwear, glycemic control; offloading casts, hyperbaric oxygen, and vascular surgery for salvage.

Read full article

Keywords: diabetic foot ulcer, neuropathy, osteomyelitis, amputation prevention, monofilament testing

Diabetic Foot Ulcers Heal Quickly with Nitric Oxide Technology

Editors Note: This article starts by claiming that “15% of 425 million people in the U.S. living with diabetes develop foot ulcers”. So ….

15% of the 425 million people in the U.S. living with diabetes develop foot ulcers. This is called diabetic foot ulcers, and it is said to increase the risk of death on a person by up to 2.5 times. Treating the ulcer with current means takes around 120 days … Now, with a nitric oxide-releasing technology, a team of biometric engineers say they can reduce the healing time of this diabetic foot ulcer by 99 days – that is from 120 to only 21 days … In the quest to lower these expenses, experts from Michigan Technological University have created what they call a nitric oxide-laden bandage that monitors, adjusts and releases the chemical, based on the need or depending on the state of the cells … To arrive at that, they first investigated what goes inside the skin cells when nitric oxide was introduced. In this case, the focus was on dermal fibroblast cells, which they analyzed on both normal and diabetic human cells … read more

Temperature-reading ‘smartmat’ catches diabetic foot ulcers early

Podimetrics, a startup created during an MIT “hackathon” in 2011, focuses on catching foot ulcers—a complication of diabetes that can lead to amputation—early. The company unveiled data showing its remote-monitoring technology caught a majority of foot ulcers well before they appeared.

A number of factors contribute to the development of diabetic foot ulcers, including nerve damage, which stops patients from feeling small injuries in their foot. A healthy person might change his or her movement or adjust a shoe, but a person with diabetes-related nerve damage will not notice the pain. Repetitive injury over time can lead to an ulcer, and early detection can help prevent an ulcer from forming or getting worse … read more

More:
Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers

Podimetrics website

Posted in Articles

Aurealis Therapeutics receives CTA approval for AUP-16 Phase 2 RCT in Diabetic Foot Ulcer patients

by admin on May 22, 2023

…perspective. AUP-16 is topically applied on chronic wounds and covered by wound dressing (e.g. in diabetic foot ulcers, venous leg ulcers and pressure ulcers). In the wound AUP-16 acts as…

Diabetic Foot Ulcer Classification Models Using Artificial Intelligence and Machine Learning Techniques

Diabetic Foot Ulcer Classification Models Using Artificial Intelligence and Machine Learning Techniques: Systematic Review

Summary: This systematic review examines the performance and limitations of machine learning (ML) models developed to classify and prognosticate diabetic foot ulcer (DFU) outcomes. The authors aggregated evidence from 13 papers across 11 studies, scrutinizing model variety, prediction accuracy, and methodological quality, and call for future work on externally validated and interpretable models.

Key Highlights:

Scope: 11 studies (13 publications) were included, assessing ML models for outcomes such as wound healing, lower extremity amputation (LEA), and mortality.

Model performance: Models reported area under the ROC curve (AUROC) values ranging from 0.56 to 0.94; many reached ≥0.8, indicating good discrimination.

Bias & limitations: All examined studies had a high risk of bias due to inconsistent definitions, small sample sizes, and poor handling of missing data.

Common predictors: Frequent variables included wound area, demographic factors, lab values, and foot-specific clinical features.

Gaps identified: Few models underwent external validation or assessed calibration; most used opaque (non-explainable) algorithms, limiting clinical applicability.

Future direction: The authors emphasize the need for ML models that are explainable, externally validated, and integrated into clinical workflows before deployment in DFU care.

Read the full review on JMIR

Keywords:
artificial intelligence,
machine learning,
diabetic foot ulcer,
classification models,
Manuel Alberto Silva,
Emma J Hamilton,
David A Russell,
Fran Game,
Sheila C Wang,
Sofia Baptista,
Matilde Monteiro-Soares

Reusable Fiberglass & Polyester Combined Total Contact Cast System for Plantar Diabetic Foot Ulcers

Reusable Fiberglass & Polyester Combined Total Contact Cast System for Plantar Diabetic Foot Ulcers: Efficacy & Cost-Effectiveness

Summary: A retrospective study at Sakarya University evaluated a hybrid total contact cast (TCC) system made of fiberglass and polyester that can be reused in the treatment of plantar diabetic foot ulcers unresponsive to standard care. Results showed strong healing rates, comparable performance across ulcer sites, and potential cost advantages, suggesting this system could be a sustainable option in wound care.

Key Highlights:

Healing rates: 75.7% of patients (53 out of 70) achieved complete wound closure.

Non-healing outcomes: Of 17 patients who did not heal, 9 required minor amputation and 1 required a major amputation.

Time to heal: Median closure time was ~64.5 days for forefoot ulcers and ~84.5 days for hindfoot ulcers, with no significant differences by location.

Patient profile: Average patient age was 57 years; many had long-standing diabetes with peripheral neuropathy, and 5 patients presented with peripheral arterial disease.

Cast design: The semi-rigid toe-to-knee system combined a rigid fiberglass structure with soft polyester wraps. Casts were reused after inspection and cleaning.

Cost and sustainability: While no formal economic analysis was completed, the reusable design reduces waste and may lower overall treatment costs.

Limitations: As a single-center, retrospective study, results need validation in larger multicenter prospective trials. Patient comfort and adherence should also be explored further.

Read the full article in Frontiers in Endocrinology

Keywords:
diabetic foot ulcer,
total contact cast,
offloading,
reusable cast,
cost effectiveness,
wound healing time

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers: A Multicentre Retrospective Case Series

Summary: This retrospective multicentre study assessed the clinical outcomes of applying hypothermically stored amniotic membrane (HSAM) in chronic diabetic foot ulcers. Treatment led to faster epithelialization, improved granulation tissue, and reduced inflammation compared with standard care.

Key Highlights:

Evaluated HSAM’s role in difficult-to-heal diabetic ulcers.

Observed accelerated closure and reduced infection risk.

Highlighted regenerative and anti-inflammatory effects.

Supports HSAM as an adjunct in chronic wound management.

Read full article

Keywords:
amniotic membrane,
diabetic foot ulcer,
wound healing,
HSAM

Ethacridine Targets Bacterial Biofilms in Diabetic Foot Ulcers

Ethacridine Targets Bacterial Biofilms in Diabetic Foot Ulcers: Multi-Target Mechanisms

Summary: This study elucidates ethacridine’s antibacterial mechanisms in diabetic foot ulcers (DFUs) through integrated network pharmacology, molecular docking, molecular dynamics (MD) simulation, and clinical RT-qPCR validation. Identifying 105 overlapping targets, ethacridine modulates hub genes like AKT1 and MMP9, enriching in oxidative stress, inflammation, and bacterial response pathways (e.g., AGE–RAGE, TNF, IL-17). Docking confirmed strong MMP9 binding (−9.8 kcal/mol), with MD simulations verifying complex stability. In DFU patient tissues, RT-qPCR showed upregulated pro-healing genes (AKT1, HSP90AA1) and downregulated inflammatory/degradative ones (MMP9, MAPK8; p<0.0001). As a safe topical agent, ethacridine disrupts biofilms, mitigates inflammation, and fosters regeneration, offering a multi-functional approach to combat DFU infections and reduce amputations.

Key Highlights:

Network analysis identified 105 common targets, with 10 hubs (e.g., AKT1, EGFR, MMP9) linked to oxidative stress, inflammation, and bacterial defense GO terms.

KEGG pathways enriched in AGE–RAGE, TNF, and IL-17 signaling, underscoring ethacridine’s role in diabetic complications and biofilm disruption.

Molecular docking: Binding energies < −5.0 kcal/mol, strongest for MMP9 (−9.8 kcal/mol); MD simulation: Stable complex (RMSD < 2.4 Å, ~2 H-bonds).

RT-qPCR in 20 DFU patients: Upregulated AKT1/HSP90AA1 (p<0.0001) for survival/angiogenesis; downregulated MMP9/MAPK8 (p<0.0001) for matrix preservation and inflammation control.

Implications: Topical ethacridine as affordable biofilm eradicator; future trials needed for resistance and efficacy in chronic wound management.

Read full article

Keywords: ethacridine, diabetic foot ulcers, bacterial biofilms, network pharmacology, molecular docking, Tianbo Li, Yuming Zhuang, Jiangning Wang

Early Clinical Experience with a Topical Desiccating Agent for Wound Bed Preparation in Diabetic Foot Ulcers

Early Clinical Experience with a Topical Desiccating Agent for Wound Bed Preparation in Diabetic Foot Ulcers

Summary: This retrospective case series evaluates the clinical outcomes of a novel topical desiccating agent (TDA) used under a compassionate-use protocol for wound bed preparation in 67 patients with hard-to-heal (chronic) diabetic foot ulcers (DFUs) treated between 2020 and 2023. The TDA, applied topically, facilitated effective debridement and promoted granulation tissue formation, leading to granulation in 88.1% of cases (mean time: 44.3 days) and complete re-epithelialization in 85.1% of patients. No adverse events were reported, and the agent was well-tolerated in this high-risk population, suggesting its potential as a safe, non-invasive adjunct to standard care. Further prospective studies are recommended to confirm these promising results.

Key Highlights:

Patient cohort: 67 adults with chronic DFUs; treated under institutional ethics-approved compassionate-use protocol from 2020-2023.

Granulation achievement: 88.1% of patients (mean time to granulation: 44.3 days), indicating rapid wound bed preparation.

Healing outcomes: 85.1% reached complete re-epithelialization, highlighting TDA’s efficacy in promoting full closure.

Safety profile: No adverse events reported; well-tolerated across all applications, suitable for high-risk diabetic populations.

Implications: TDA offers a novel, clinic-applicable chemical debridement option; supports further evaluation in controlled trials for DFU management.

Read full article

Keywords: topical desiccating agent, diabetic foot ulcers, wound bed preparation, chemical debridement, granulation tissue, Johannes P Snels, Bart J Q van Luijk, Arjan C Assendelft

DAE Launches India’s First Nitric-Oxide Wound Dressing for Diabetic Foot Ulcers

DAE Launches India’s First Nitric-Oxide Wound Dressing for Diabetic Foot Ulcers

Summary: The Department of Atomic Energy (DAE) launched ColoNoX, India’s first nitric-oxide (NO)-releasing wound dressing for diabetic foot ulcers (DFUs), developed by Bhabha Atomic Research Centre (BARC) and validated in Phase II/III trials. The DCGI-approved product enhances angiogenesis and antimicrobial action, accelerating healing in 70% of cases and reducing amputation risks by 40% in resource-limited settings. Affordable and locally produced, it addresses India’s 77M diabetics, with rollout via public-private partnerships for nationwide access.

Key Highlights:

ColoNoX: NO from chitosan matrix promotes vascularization and kills bacteria without resistance.

Trials: Phase II/III show 70% faster granulation; 40% amputation reduction vs standard dressings.

Impact: Targets 15% DFU incidence; cost-effective for rural care.

Launch: DAE/BARC initiative; partnerships for distribution.

Quote: DAE Secretary: “Breakthrough for diabetic complications in India.”

Read full article

Keywords: nitric oxide dressing, diabetic foot ulcers, ColoNoX, BARC, amputation reduction

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

Summary: A pilot study evaluated the GPP@ZnBG hydrogel—a self-regulating bioactive glass-embedded system—for chronic diabetic foot ulcers. The hydrogel dynamically responds to wound pH and glucose/oxidative stress: early alkaline conditions trigger controlled zinc ion release for antibacterial effects, while later degradation releases zinc, calcium, and silicate ions to promote angiogenesis and tissue repair. In the clinical pilot, treated ulcers showed a 94.57% relative reduction in wound surface area within 4 weeks. This active nanotechnology approach addresses persistent infection, inflammation, and impaired healing better than passive standard care and highlights pharmacists’ role in advanced product selection and patient education.

Key Highlights:

94.57% wound area reduction in 4 weeks for chronic DFU

pH-responsive zinc delivery: antibacterial early, pro-angiogenic later

Addresses biofilm, ROS, and poor perfusion in diabetic wounds

Study authors: Zhao L, Chen S, Chen S, et al.

Read full article

Keywords: DFU hydrogel, bioactive glass wound care, chronic diabetic foot ulcer, zinc ion therapy

Diabetic Foot Ulcer Healing Better Predicted with Thermal Imaging

Diabetic Foot Ulcer Healing Better Predicted with Thermal Imaging

Summary: Collaborative research from RMIT University, University of Melbourne, and Austin Health demonstrates that thermal imaging enhances prediction of diabetic foot ulcer healing. The non-contact technique provides objective data on wound temperature patterns that correlate with healing progression and final ulcer size.

Key Highlights:

First-of-its-kind study combining thermal imaging with clinical assessment

Improved prediction of both healing trajectory and final wound size

Non-invasive, objective tool for DFU monitoring

Potential for earlier intervention in non-healing ulcers

Read full article

Keywords: thermal imaging DFU, diabetic foot ulcer prediction

Posted in

Resources

by admin on January 18, 2018

…Diabetic Foot & Wound Management. Discussion about diabetic foot complications, management of wounds and peripheral vascular diseases. Our scars & wound care forums provide you with the opportunity to discuss…

True impact of diabetic foot ulcers

The prognosis for people with an infected diabetic foot ulcer is worse than was previously thought, according to new research … More than half the patients in the research study did not see their ulcer heal over a year — and one in seven had to have part or all of their foot amputated … Foot ulcers are open wounds and they affect around a quarter of the 3.3 million people in the UK living with diabetes … The wounds develop because diabetes damages the nerves and blood vessels in the feet … These wounds are chronic, slow to heal and prone to infection, and it is infection that normally leads to some of the severe consequences such as losing a limb or multiple amputations … read more

The time is now for stewardship in diabetic foot infections

Diabetes, first described in ancient Egypt, remains at the forefront of health care in modern times. Roughly 537 million adults aged 20 to 79 years are living with diabetes worldwide, a number expected to rise over the next decades … Diabetic complications are vast. Diabetic foot infection (DFI) is a chronic, more severe complication that affects roughly 15% of people with diabetes. DFIs have been associated with decreased quality of life, frequent and prolonged hospitalizations and greater risk for lower extremity amputation … read more

Technology-Enhanced Diabetic Foot Ulcer Management

Technology-Enhanced Diabetic Foot Ulcer Management

Summary: In this interview, Dr. Jonathan Johnson, MD, MBA, CWSP, highlights emerging imaging technologies that go beyond visual assessment for diabetic foot ulcers. Tools such as fluorescence imaging (for bioburden), thermal imaging (for perfusion/infection), and digital measurement enable earlier detection of complications, better documentation, real-time decision-making for debridement and offloading, and more standardized care in diverse settings.

Key Highlights:

Fluorescence and thermal imaging detect infection/ischemia earlier than visual exam

Digital tools improve documentation, measurement accuracy, and continuity

Supports better decisions on debridement, offloading, and vascular referral

Scalable across outpatient, home, and hospital environments

Read full article

Keywords: DFU imaging, fluorescence wound imaging, technology DFU

Global Preventive Foot Care And A Decrease In Amputations

Global Preventive Foot Care Delivers Promising Reductions in Amputations

Featured in *Limb Preservation Journal* (Vol 6 No 1, Wounds Canada), this initiative outlines a comprehensive training program—Train the Foot Healthcare Professional (TtFHCP)—implemented across six WHO regions from 2023 to 2025. The goal: empower local providers to effectively screen, assess, and manage diabetic foot complications with minimal resource dependence. Download the full PDF.

Key Highlights:

Program Reach: Delivered in six WHO regions, TtFHCP enhances the skills of clinicians and allied professionals in foot screening, offloading, callus care, and ulcer recognition. :contentReference[oaicite:1]{index=1}

Improved Outcomes: Early results indicate reductions in ulcer incidence and need for amputation in trained communities, reinforcing the value of proactive foot care. :contentReference[oaicite:2]{index=2}

Resource-Level Strategies: Emphasis on practical interventions—callus removal, offloading, patient education—designed for implementation in settings with limited access to specialized wound services. :contentReference[oaicite:3]{index=3}

Introducing STIMULAN®: In locations where foot infections occurred despite preventive care, localized antibiotic therapy using **Stimulan®** calcium sulfate beads was trialed. This infection-focused strategy aims to reduce progression to diabetic foot osteomyelitis, supported by emerging clinical and in vitro evidence. :contentReference[oaicite:4]{index=4}

This program exemplifies how scalable, education-driven preventive foot care—augmented with available adjunct therapies like local antibiotic-loaded beads—can significantly reduce diabetic foot complications on a global scale.

Read the full report and download the PDF from Wounds Canada via the link above.

Keywords:
preventive foot care,
diabetic foot complications,
amputation prevention,
Stimulan® beads,
local antibiotic therapy

🔬 Product Spotlight: Stimulan® in Global Wound Care

As part of adjunctive care in settings with recurrent or hard-to-control infections, **Stimulan®** calcium sulfate beads are gaining traction. These absorbable beads can be loaded with antibiotics like vancomycin or gentamicin and placed directly into the wound site—providing high local antibiotic concentrations while minimizing systemic exposure. In early-stage wound infections identified through the TtFHCP model, Stimulan® offers a promising tool to halt bacterial spread and support tissue preservation, even in low-resource environments.

Its role in limb salvage continues to grow as more programs integrate localized antimicrobial delivery into diabetic foot protocols. Clinicians using Stimulan® report reduced recurrence rates and improved wound bed preparation prior to definitive closure or offloading.

Core Services from a Multidisciplinary Diabetic Foot Team

Core Services from a Multidisciplinary Diabetic Foot Team (ZAP Position Statement)

A position statement by the Zero All Preventable (ZAP) Amputation group of Foot in Diabetes UK (FDUK), published April 15, 2025 in The Diabetic Foot Journal, outlines the essential services that people with active diabetic foot problems should expect from a multidisciplinary diabetic foot team (MDFT).

Key Highlights:

Team Composition: Core members should include podiatrists, diabetologists, vascular specialists, orthopaedic or podiatric surgeons, plastic surgeons, microbiologists or infectious disease physicians, specialist nurses, psychologists, orthotists, and plaster technicians—all coordinated by a designated MDFT lead.

Timely Intervention: Debridement should be performed without delay—typically by a podiatrist—with immediate offloading and pressure redistribution initiated to reduce further tissue damage.

Infection and Vascular Management: Patients should have rapid access to antibiotics and surgical debridement for infected wounds, alongside urgent vascular imaging and revascularization when ischemia is suspected.

Referral and Prescribing Rights: Podiatrists should hold independent referral rights for imaging (e.g., X-ray, MRI) and, where supported, prescribing authority. Dedicated consultant podiatrists should oversee care coordination across both inpatient and outpatient settings.

Mental Health Integration: Recognizing the emotional burden and high mortality rates associated with diabetic foot ulcers, mental health support must be embedded through liaison nurses or access to psychological services.

This position paper reinforces that fully staffed, responsive, and coordinated multidisciplinary teams—led by experienced podiatric clinicians—are critical in delivering timely care and reducing amputation risk in individuals with diabetes.

Read the full position statement on the Diabetic Foot Journal website.

Keywords:
ZAP Amputation,
multidisciplinary foot team,
debridement,
offloading,
psychological support

Six-month Outcomes of Patients Admitted for Diabetic Foot Attack

Mid-Term Outcomes in Patients Hospitalized for Diabetic Foot Attack

A retrospective observational study published in Therapeutic Advances in Endocrinology and Metabolism assessed six-month outcomes of patients admitted to a multidisciplinary diabetic foot service for diabetic foot ulcers (DFUs), comparing those with a Diabetic Foot Attack (DFA) to those with Chronic Diabetic Foot (CDF) conditions.

Study Overview:

Population: 141 patients, mean age 70 ± 12 years; majority male (76.6%) with type 2 diabetes (93.6%) of mean duration 22 ± 13 years.

Group Definitions: DFA patients had acute ischemia, moderate/severe infections, or urgent conditions requiring hospitalization. CDF patients were admitted electively for chronic DFUs.

DFA Characteristics: Higher rates of moderate/severe infection (81.5% vs 50% in CDF), higher HbA1c levels (67 ± 22 vs 56 ± 14 mmol/mol), and more first-time DFU assessments (59.3% vs 13.3%).

Six-Month Outcomes (DFA vs CDF):

Healing: 65.4% vs 60.0% (p = 0.3)

Major Amputation: 4.9% vs 1.7% (p = 0.2)

Mortality: 8.6% vs 11.7% (p = 0.5)

Hospital Readmission: 27.2% vs 26.7% (p = 0.8)

Non-fatal MALCE: 9.9% vs 23.3% (p = 0.1)

Conclusion: Despite more severe initial presentations, patients hospitalized with DFA experienced similar six-month outcomes compared to those with CDF, suggesting that urgent multidisciplinary management may lead to favorable mid-term results.

Keywords:
diabetic foot attack,
chronic diabetic foot,
DFU,
amputation risk,
hospital readmission,
MALCE,
HbA1c,
multidisciplinary wound care

Read the full study in Therapeutic Advances in Endocrinology and Metabolism

Study shows how management of serious diabetic foot ulcers was possible during the COVID-19 lockdown

New research being presented at the European Association for the Study of Diabetes (EASD), held online this year (27 Sept-1 Oct), reveals how Belgium’s efforts to maintain a diabetic foot care programme during the COVID-19 pandemic can offer valuable lessons to the rest of the world.

“Thanks to the great efforts of diabetic foot clinics, continued availability of diabetic foot ulcer services during lockdown, although in a limited capacity, were really helpful, and may be the reason why we didn’t see late presentation and the impact on the severity of ulcers was limited to slightly larger wounds”, says lead author Dr An-Sofie Vanherwegen from Sciensano, Brussels, Belgium. “Our findings will hopefully guide diabetic foot clinics in serving their patients using innovative strategies … read more

Sucrose octasulfate wound dressing may speed healing in diabetic foot ulcers

Patients with a noninfected neuroischemic diabetic foot ulcer were more likely to achieve wound closure within 20 weeks when randomly assigned a sucrose octasulfate dressing vs. those assigned a standard wound dressing, according to findings published in The Lancet Diabetes & Endocrinology.

“Delayed wound healing in neuroischemic diabetic foot ulcers has been related to excess matrix metalloprotease concentrations; these proteins destroy components of the extracellular matrix and damage growth factors and their receptors that are essential for healing,” Michael Edmonds, MD, of the Diabetic Foot Clinic at King’s College Hospital in London, and colleagues wrote. “Sulfated oligosaccharides are known to have many biological activities; in particular, the potassium salt of sucrose octasulfate has been shown to inhibit matrix metalloproteases and to interact with growth factors and restore their biological functions because it has high charge density.”

Edmonds and colleagues analyzed data from 240 patients with diabetes and a noninfected neuroischemic diabetic foot ulcer of grade IC or IIC, with a wound … read more

Higher rates of all-cause mortality and resource utilization during episodes-of-care for diabetic foot ulceration

Researchers aimed at ascertaining if higher all-cause rates of mortality and resource utilization are recorded during periods of diabetic foot ulceration. In addition, an episode-of-care model for diabetic foot ulceration has been developed and validated.

The Medicare Limited Data Set between 2013 and 2019 was analyzed for retrieval of data for this study.

Episodes-of-care were defined by clustering diabetic foot ulcer linked claims such that the longest time interval between consecutive claims in any cluster did not extend beyond a duration which was adjusted to match two characteristics of foot ulcer

… read more

Diabetic foot ulcers associated with mortality, hospitalization for chronic conditions

Diabetic foot ulcer episodes were associated with all-cause mortality and all-cause inpatient hospital admissions, according to new results published in Diabetes Research and Clinical Practice … “The impact of diabetic foot ulcers has been historically difficult to quantify, but our study shows that these foot wounds are associated with higher rates of all-cause hospitalization and all-cause mortality,” Brian J. Peterson, co-founder and chief scientist at Podimetrics, told Healio. “In our research, we found that during episodes-of-care for diabetic foot ulcers, individuals are 50% more likely to die and nearly three times more likely to be hospitalized.” … read more

Incidence and Predictors of Diabetic Foot Ulcers in Ethiopian Diabetes Patients

Incidence and Predictors of Diabetic Foot Ulcers in Ethiopian Diabetes Patients

Summary: This retrospective cohort study at Debre Berhan Comprehensive Specialized Hospital in Ethiopia (2005–2021) tracked 321 newly diagnosed adult diabetes patients, finding a cumulative diabetic foot ulcer (DFU) incidence of 11.8% (1.01 per 100 person-years). Key predictors included older age (≥70 years, AHR=15.025), rural residence (AHR=2.731), hypertension (AHR=5.609), obesity (AHR=2.936), neuropathy (AHR=4.583), and abnormal HDL levels (AHR=3.713). Using Cox regression and Kaplan-Meier analysis, the study underscores the need for early screening and education to prevent complications like amputations in resource-limited settings.

Key Highlights:

Cumulative DFU incidence of 11.8%, with higher risks in older patients and those with neuropathy or hypertension.

Rural residence doubles DFU risk due to limited access to foot care and education.

Obesity and low HDL levels significantly elevate odds, linking metabolic factors to delayed wound healing.

Study calls for integrated policies emphasizing screening and self-management to reduce amputation rates.

Limitations include incomplete data and lack of behavioral factors, highlighting needs for prospective research.

Read full article

Keywords:
diabetic foot ulcers,
DFU predictors,
diabetes complications,
rural wound care,
wound prevention

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers: A Multicentre Retrospective Case Series

Summary: Researchers from US-based wound care sites published a multicentre retrospective case series in the Journal of Wound Care (March 2024 supplement) reporting clinical outcomes for diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM), a cellular, acellular and matrix-like product (CAMP) classified as a human cellular and tissue-based product (HCT/P) under FDA oversight. HSAM differs from dehydrated and cryopreserved amniotic membrane allografts in that hypothermic storage conditions preserve viable differentiated and stem cell populations, growth factors, cytokines, and extracellular matrix proteins more completely — a distinction the authors argue may enhance clinical effectiveness. The study enrolled 50 patients across multiple US wound care sites; 68% were male with a mean age of 66.7 years. The majority of DFUs (88%) were present for fewer than 6 months at first presentation, and mean wound area at first presentation was 3.5 cm². From first presentation to baseline (the visit at which HSAM was first applied), mean percentage wound area reduction was −68.3%, reflecting the contribution of standard of care (SoC) pre-treatment. HSAM was then applied on top of continued SoC, and patients were followed over 12 weeks. The results suggest positive outcomes in terms of continued wound closure, with reduction in time to complete wound closure (CWC) noted as a key patient benefit — since shortened healing time translates to reduced financial burden and improved quality of life. The case series adds real-world evidence to prior randomized controlled trial data for HSAM in DFUs, including a 14-site RCT (Serena et al., 2020) that demonstrated a 60% closure rate at 12 weeks and a 75% greater probability of weekly wound closure versus standard of care alone.

Key Highlights:

50 patients across multiple US wound care sites; 68% male, mean age 66.7 years; 88% of DFUs present <6 months at first presentation

Mean wound area 3.5 cm²; mean percentage area reduction of −68.3% from first presentation to HSAM baseline (reflecting SoC pre-treatment effect)

HSAM mechanism: hypothermic storage preserves viable cells, stem cells, growth factors, cytokines, and ECM proteins — a key advantage over dehydrated and cryopreserved amnion products

Prior RCT (Serena et al., 2020, n=76): HSAM produced 60% closure at 12 weeks vs. 38% SoC (p=0.004) and 75% greater probability of wound closure on a weekly basis over 16 weeks

Shortened time to CWC cited as having downstream financial and quality-of-life benefits — average DFU cost estimated at $38,000–$54,000 if leading to amputation

Authors: Anna Sanchez (San Antonio New Step, TX), Alan Hartstein and Hisham Ashry (Palm Beach Foot & Ankle, FL), Maryam Raza; data coordination supported by Organogenesis Inc.

Read full article

Keywords: amniotic membrane wound care, hypothermically stored amniotic membrane, diabetic foot ulcer CAMPs, placental allograft wound, HSAM DFU, cellular tissue products wound healing

Anna Sanchez Alan Hartstein Hisham Ashry Maryam Raza

Lipodystrophy, a Common Risk in Diabetic Foot Ulcers

Patients with lipodystrophy have a high risk of diabetic foot ulcers, especially in the younger population.

Lipodystrophy is a disorder characterized by an abnormal fat distribution in the body. It can refer to an irregular loss or accumulation of fat tissue, and can even cause macrovascular and microvascular complications. Diabetic foot ulcers are a chronic complication of diabetes that can cause loss of lower limbs from amputations. DFU is also a risk factor in diabetes-related mortality. Previous studies have not found a correlation between lipodystrophy and DFU or even a treatment to reduce these complications. Lipodystrophy is a complication caused mainly by familial partial lipodystrophy. This study used an observational retrospective cohort study to understand the correlation between these two disorders, lipodystrophy and diabetic foot ulcers, and which age was the most critical … read more

Low Vitamin D Links With Increased Diabetic Foot Ulcers

Researchers published the study covered in this summary on researchsquare.com as a preprint that has not yet been peer reviewed.

Key Takeaways

Low serum levels of vitamin D were significantly associated with a higher prevalence of diabetic foot ulcers in elderly patients with diabetes.

Average serum levels of 25-hydroxy-vitamin D (25-OH-D) (vitamin D₃, the major circulating form of vitamin D in people) steadily decreased as the severity of diabetic foot ulcers increased, as measured by the Wagner classification.

Elderly people with diabetes should undergo routine vitamin D screening or receive vitamin D supplementation to prevent the onset or improve the prognosis of diabetic foot ulcers, the authors say.

… read more

Innovative Approaches in Diabetic Foot Ulcer Management

From LEKHA MUTYALA
Summary:
Revolutionizing Diabetic Foot Ulcer Care with 3D Technology
Diabetic foot ulcers (DFUs) affect 1 in 4 individuals with diabetes and contribute significantly to healthcare costs and lower limb amputations worldwide. Traditional treatments—like wound debridement, glycemic control, and surgical interventions—offer limited scalability in the face of rising diabetes prevalence. Fortunately, innovative technologies are reshaping the future of DFU management. 3D-printed antibiotic bandages from Queen’s University promise rapid healing and reduced clinical burden. Meanwhile, Indian researchers have developed custom, pressure-sensitive 3D-printed footwear to enhance balance and recovery. In surgical care, 3D-bioprinted adipose tissue has successfully prevented amputations in high-risk patients. These advancements highlight how personalized, tech-driven solutions can reduce complications, improve outcomes, and lower healthcare costs for diabetic patients. Full article

————

Lekha Mutyala is a podiatry student at Kent State University College of Podiatric Medicine (KSUCPM). In 2024, she won the 38th Annual American Podiatric Medical Writers Association (APMWA) Student Writing Competition for her paper titled “Advancements in Technology and Innovative Approaches in Diabetic Foot Ulcer Management.” This achievement earned her a $1,000 honorarium from an endowment by Dr. and Mrs. Steven Berlin to the APMA Educational Foundation .

Additionally, Mutyala was recognized as a 2024–2025 APMA Educational Foundation scholarship recipient, highlighting her academic excellence and commitment to the field of podiatric medicine

Fibroblast technology developed for diabetic foot ulcers, chronic wounds

Fibroblast Technology Developed for Diabetic Foot Ulcers and Chronic Wounds

FibroBiologics, in collaboration with Charles River, has announced the completion of a master cell bank for a novel fibroblast-based therapy aimed at treating chronic wounds, including diabetic foot ulcers (DFUs). The product, designated CYWC628, utilizes a spheroid approach to deliver fibroblast cells topically, promoting wound healing by releasing essential growth factors and cytokines.

According to Dr. Hamid Khoja, Chief Scientific Officer at FibroBiologics, “Fibroblasts are involved in every single stage of the wound healing process.” He notes that chronic wounds like DFUs often fail to heal due to cellular senescence, and this new therapy aims to address that by rejuvenating the wound environment.

CYWC628 has passed all required safety testing, and clinical trials are scheduled to commence in the second quarter of 2025. The 12-week study will evaluate the product’s efficacy in promoting healing in patients with chronic wounds.

Read the full article on the Healio website.

Keywords:
Fibroblast therapy,
Chronic wounds,
Diabetic foot ulcers,
CYWC628,
Wound healing,
Cell-based therapy,
Growth factors,
Clinical trials,
Cellular senescence

Age Characteristics of Patients With Type 2 Diabetic Foot Ulcers

Age Characteristics of Patients With Type 2 Diabetic Foot Ulcers and Predictive Risk Factors for Lower Limb Amputation: A Population-Based Retrospective Study

A population-based retrospective study published in the Journal of Diabetes Research analyzed data from 918 patients with type 2 diabetic foot ulcers (DFUs) treated between 2017 and 2023 at The First Affiliated Hospital of Wannan Medical College in Wuhu, China. The study aimed to investigate age-related characteristics and identify key risk factors associated with lower limb amputation in this patient population.

The findings revealed that the majority of DFU patients were aged between 50 and 59 years, with a notable peak in mortality observed among those aged 70 to 79. Logistic regression analysis identified several significant predictors for lower extremity amputation, including a history of prior amputation, presence of vascular complications, infection sites, and hemoglobin levels. Specifically, a history of amputation and low hemoglobin were strongly associated with major amputations.

These insights underscore the importance of early identification and management of risk factors to prevent severe outcomes in patients with DFUs, particularly in middle-aged and older populations.

Read the full article on the Journal of Diabetes Research website.

Keywords:
Type 2 diabetes,
Diabetic foot ulcers,
Lower limb amputation,
Risk factors,
Yuanying Yao,
Lei Chen,
Yu Qian

How Effective Is Bromelain-based Debridement (BBD) in Diabetic Foot Ulcers?

How Effective Is Bromelain-based Debridement (BBD) in Diabetic Foot Ulcers?

At the Symposium on Advanced Wound Care (SAWC) Spring, a poster presented by Brian McCurdy highlighted the potential benefits of bromelain-based debridement (BBD) for diabetic foot ulcers (DFUs). The post-hoc analysis involved 19 patients, with 12 receiving BBD 5% and 7 receiving a gel vehicle control. Treatments were administered daily for up to 10 sessions over two weeks, followed by weekly assessments for 12 weeks.

Key Findings:

Complete Debridement: Achieved in 58% of BBD patients compared to 14% in the control group within the two-week treatment period.

Granulation Tissue Formation: ≥75% granulation observed in a higher proportion of BBD-treated wounds, indicating enhanced wound bed preparation.

Wound Closure: Defined as complete epithelialization without drainage or dressing use for two weeks, was more frequently attained in the BBD group.

While the subgroup analysis was not powered to detect statistically significant differences, the results suggest that BBD may offer advantages over traditional gel vehicle debridement in promoting wound healing in DFUs.

Read the full article on the HMP Global Learning Network website.

Keywords:
Bromelain-based debridement,
Diabetic foot ulcers,
Wound healing,
Enzymatic debridement,
Brian McCurdy

Mesenchymal Stem Cell-Derived Exosomes Hold Promise in the Treatment of Diabetic Foot Ulcers

Mesenchymal Stem Cell-Derived Exosomes: A Promising Therapeutic Avenue for Diabetic Foot Ulcers

Recent research highlights the potential of mesenchymal stem cell (MSC)-derived exosomes as a novel treatment for diabetic foot ulcers (DFUs). These nano-sized vesicles, secreted by MSCs, are rich in bioactive molecules that can modulate various aspects of the wound healing process.

Key Mechanisms:

Anti-inflammatory Effects: MSC-derived exosomes can reduce inflammation by modulating immune cell responses, thereby creating a conducive environment for healing.

Promotion of Angiogenesis: They stimulate the formation of new blood vessels, ensuring adequate oxygen and nutrient supply to the wound site.

Enhancement of Cell Proliferation and Migration: Exosomes encourage the proliferation and migration of skin cells, essential for tissue regeneration.

Extracellular Matrix Remodeling: They aid in the remodeling of the extracellular matrix, providing structural support for new tissue formation.

These multifaceted actions position MSC-derived exosomes as a promising cell-free therapeutic strategy for DFUs, potentially overcoming limitations associated with direct stem cell therapies.

Read the full article on the Dove Medical Press website.

Keywords:
Mesenchymal stem cells,
Exosomes,
Diabetic foot ulcers,
Regenerative medicine,
Cell-free therapy

Use of hypothermically stored amniotic membrane on diabetic foot ulcers

Hypothermically Stored Amniotic Membrane Shows Promise in Diabetic Foot Ulcer Healing

A multicenter retrospective case series published in Wound Care Professional evaluated the effectiveness of hypothermically stored amniotic membrane (HSAM) in the treatment of diabetic foot ulcers (DFUs). Conducted across several U.S. wound care centers, the study followed 50 patients over a 12-week period to assess healing outcomes, wound size reduction, and frequency of treatment applications.

Key Highlights:

Patient Profile: The average patient age was 66.7 years, with 68% male participants. Most wounds (88%) had been present for less than six months at the time of initial evaluation.

Wound Area Reduction: Between initial presentation and the first HSAM application, wound area decreased by an average of 68.3%, indicating substantial early progress under standard care alone.

Wound Closure Outcomes: By week 12, 78% of DFUs had completely closed. The median time to full closure was 55 days, with an average of 5.5 HSAM applications per patient, spaced approximately 7.5 days apart.

These findings suggest that HSAM, when added to standard DFU care, may accelerate wound healing, potentially reducing the risk of complications and lowering long-term treatment costs. The high closure rate within 12 weeks is especially notable in a population with typically slow-to-heal wounds. This study adds to the growing body of evidence supporting the role of biologically active grafts in managing complex diabetic wounds.

Read the full article on the Wound Care Professional website.

Keywords:
HSAM,
diabetic foot ulcers,
wound healing,
Anna Sanchez,
Alan Hartstein,
Hisham Ashry,
Maryam Raza

Research Roundup- vol 4(1) – HSAM for treating diabetic foot ulcers

Research Roundup: Advanced Therapies for Chronic Wounds

The February 2025 issue of *Wound Care Professional* highlights three significant studies evaluating advanced biological and scaffold therapies for non-healing wounds.

Key Highlights:

Hypothermically Stored Amniotic Membrane (HSAM) for DFUs: A multicenter retrospective series (50 patients, mean age 66.7) treated diabetic foot ulcers with HSAM and observed >60% wound area reduction in 96%, and 78% complete closure by 12 weeks (median time: 55 days).

Dehydrated Human Amnion/Chorion Membrane (DHACM) in Venous Leg Ulcers: A cost-effectiveness analysis demonstrated that DHACM is both effective and economical for treating VLUs in Medicare populations.

3D Acellular Collagen Matrix in Deep/Tunnelling DFUs: Retrospective case series showed promising tissue fill and wound contraction results using collagen scaffold in complex diabetic foot ulcers.

These findings reinforce the potential of amniotic and collagen-derived biological scaffolds to enhance healing in persistent chronic wounds, while also addressing cost considerations in clinical practice.

Access the full *Research Roundup* in the Wound Care Professional (Vol 4 Issue 1, Feb 2025).

Keywords:
hypothermic amniotic membrane,
dehydrated amnion/chorion membrane,
3D collagen matrix,
diabetic foot ulcer,
venous leg ulcer

Thermal Imaging Predicts Healing in Diabetic Foot and Venous Leg Ulcers

Thermal Imaging Predicts Healing in Diabetic Foot and Venous Leg Ulcers

Recent research highlights the growing role of thermal imaging—combined with advanced analytics—as a non-contact tool to predict healing trajectories in diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), offering promise for early intervention in home and clinical settings.

Key Insights:

Early Identification in DFUs: A pilot study from RMIT University, University of Melbourne, and Austin Health showed that changes in the isothermal area of new DFUs measured by thermal imaging can predict healing status at week 4—potentially allowing clinicians to identify non-healing wounds earlier than traditional methods.

Non-Contact Home Monitoring: For VLUs, thermal texture analysis—focusing on changes in pixel patterns over two weeks—was better at distinguishing between healed and unhealed wounds by week 12 than conventional area-based thermal measurements, and didn’t require strict imaging conditions like temperature or angle control.

Benefits Over Standard Imaging: Unlike RGB photography or planimetry—which need consistent conditions and physical contact—thermal texture methods are more resilient to environmental variations and avoid infection risks, making them suitable for remote patient monitoring.

AI & Future Direction: Advances in AI-powered thermal platforms may enhance risk prediction and preventive care. Early alerts based on temperature or texture shifts can enable tailored interventions, reducing reliance on in-person assessments.

In sum, texture-focused thermal imaging offers a fast, objective, remote-friendly method to flag wounds at risk of delayed healing—potentially transforming wound surveillance, especially for vulnerable patients in home care settings.

Keywords:
thermal imaging,
diabetic foot ulcer,
venous leg ulcer,
non-contact monitoring,
AI wound assessment

Read the full article on Wound Care Advisor

High Mortality & Amputation Rates After First Diabetic Foot Ulcer

High Mortality & Amputation Rates After First Diabetic Foot Ulcer: CODIA Cohort Findings

Summary: A large cohort study from Greater Paris hospitals (August 2017-October 2023) examines the one-year outcomes in over 3,100 patients hospitalized with their first diabetic foot ulcer (DFU). The findings are alarming: ~21.6% died and ~24.2% underwent lower-limb amputation within 12 months. Key risk factors for death included older age, cardiac, hepatic or renal disease, cancer history, and systemic inflammation; amputation risk was linked to male sex, peripheral artery disease, admission through emergency, and markers of inflammation.

Key Highlights:

Sample included 3,102 patients, median age ~70.7 years; 68% male.

Cumulative incidence of death within 12 months: **21.64%**.

Cumulative incidence of lower limb amputation within 12 months: **24.15%**.

Strong predictors of mortality: chronic comorbidities (heart, liver, kidney), history of cancer, and elevated systemic inflammation.

Key predictors of amputation: male gender, peripheral arterial disease, being admitted via the emergency department, and inflammation; interestingly, dementia was associated with *lower* risk of amputation.

Read the full article in Diabetes & Metabolism

Keywords:
first diabetic foot ulcer,
lower limb amputation,
one-year mortality,
peripheral artery disease,
systemic inflammation,
Julla Jean-Baptiste,
Théo Jolivet,
Candice Estellat,
Jean-François Gautier,
Florence Tubach

Reusable Fiberglass & Polyester Total Contact Cast System for Plantar Diabetic Foot Ulcers: Efficacy & Cost-Effectiveness

Reusable Fiberglass & Polyester Total Contact Cast System for Plantar Diabetic Foot Ulcers: Efficacy & Cost-Effectiveness

Summary: A retrospective study from Sakarya University in Türkiye evaluated a reusable hybrid total contact cast (TCC) combining fiberglass and polyester for plantar diabetic foot ulcers unresponsive to standard care. Results showed high healing rates, consistent closure times across ulcer sites, and potential cost savings, positioning this system as a practical and sustainable off-loading option. (Frontiers in Endocrinology)

Key Highlights:

Patient outcomes: Of 70 patients, 75.7% achieved complete wound closure, while 24.3% did not heal, with some requiring amputations.

Ulcer location: Healing times were similar across forefoot, midfoot, and hindfoot ulcers, with no significant differences noted.

Patient profile: Average patient age was 57 years; most had long-standing diabetes with peripheral neuropathy, and some presented with peripheral arterial disease.

Cast design: The semi-rigid toe-to-knee cast combined durable fiberglass with softer polyester layers, designed for reusability and strength.

Healing times: Median closure ranged from ~64.5 days (forefoot) to ~84.5 days (hindfoot), without statistically significant differences.

Cost considerations: While a formal cost analysis was not included, the reusable design reduces material waste and offers potential economic advantages, particularly in resource-limited settings.

Read the full article in Frontiers in Endocrinology

Keywords:
diabetic foot ulcer,
total contact cast,
offloading,
reusable cast,
cost effectiveness,
wound healing

Effectiveness of hyaluronic acid and its derivatives on diabetic foot ulcer

Effectiveness of hyaluronic acid and its derivatives on diabetic foot ulcer: a systematic review and meta-analysis

Summary: This systematic review and meta-analysis assessed randomized controlled trials evaluating hyaluronic acid (HA) and its derivatives in the treatment of diabetic foot ulcers (DFUs). The authors found that HA use was associated with significantly higher complete healing rates and shorter healing times, without increasing adverse events. The analysis included 7 trials involving 444 patients and 456 ulcers.

Key Highlights:

Healing rate improvement: HA use was linked to an odds ratio (OR) of ~3.92 for complete ulcer healing vs control.

Faster healing: Time to healing was reduced (SMD ≈ –0.83) in HA-treated groups.

Safety: No significant difference in adverse event rates compared to control treatments.

Subgroup findings: Both HA alone and HA combined with autograft showed benefit, though heterogeneity was higher when autografts were involved.

Limitations & future needs: Small number of trials, variable protocols, and moderate heterogeneity suggest need for larger, high-quality RCTs and standardization of HA formulations.

Read the full article on Frontiers in Endocrinology

Keywords:
Yao,
Xie,
Dai,
Huang,
hyaluronic acid,
diabetic foot ulcer,
meta-analysis,
clinical evidence

Sequence LifeScience, Inc. Announces First Patient Enrolled in Groundbreaking Clinical Trial for Diabetic Foot Ulcers

Sequence LifeScience, Inc. Announces First Patient Enrolled in Groundbreaking Clinical Trial for Diabetic Foot Ulcers

Summary: Sequence LifeScience reported first-patient-in for a prospective, multicenter trial assessing outcomes of placental membrane allografts in hard-to-heal diabetic foot ulcers.

Key Highlights:

Study aim: Evaluate wound closure and healing trajectory in chronic DFU using company’s allografts.

Design: Prospective, multicenter clinical investigation focused on hard-to-heal ulcers.

Rationale: Address persistent limb-loss risk and need for effective adjunctive biologics.

Read the press release on PR Newswire

Keywords:
Sequence LifeScience,
diabetic foot ulcer,
placental allograft,
clinical trial

Clinical Evidence and Cost-Effectiveness: Advanced Cellular Tissue Products for Diabetic Foot Ulcers

Clinical Evidence and Cost-Effectiveness: Advanced Cellular Tissue Products for Diabetic Foot Ulcers

Summary: This article provides a comprehensive review of the clinical evidence and cost-effectiveness of advanced cellular/tissue products (CTPs) for diabetic foot ulcers (DFUs), focusing on FDA-approved options like Apligraf and Dermagraft. It demonstrates their superiority over standard care in achieving higher healing rates, shorter closure times, and reduced complications such as infections and amputations, while delivering significant long-term cost savings despite initial expenses. The discussion underscores the urgent need for early intervention in DFU management amid rising diabetes prevalence.

Key Highlights:

CTPs like Apligraf (human skin equivalent) and Dermagraft (dermal skin substitute) promote faster wound closure and lower amputation risks in chronic DFUs unresponsive to standard care.

Randomized trials show up to twice the healing rates with CTPs, supported by real-world data and meta-analyses confirming reduced hospitalization and infection risks.

Economic analyses reveal per-patient savings of $5,253–$6,991 over 18 months, offsetting upfront costs through fewer emergency visits and inpatient stays.

Challenges include high DFU recurrence (50% within 1 year) and the need for prompt adjunctive therapies to prevent 1 in 6 cases from leading to amputation.

Read full article

Keywords:
diabetic foot ulcers,
cellular tissue products,
Apligraf,
Dermagraft,
cost-effective wound care

Declining Trends: Incidence, Hospitalization, and Mortality in First-Ever Diabetic Foot Ulcers

Declining Trends: Incidence, Hospitalization, and Mortality in First-Ever Diabetic Foot Ulcers

Summary: This retrospective analysis from the UK’s CPRD GOLD primary care database (2007–2017) examines the incidence, hospitalization, and mortality trends for first-ever diabetic foot ulcers (DFUs) in 129,624 people with diabetes. For type 2 diabetes, the mean incidence rate was 2.5 per 1,000 person-years, with significant annual declines (IRR 0.97), alongside reduced hospitalization (8.2% average, OR 0.89) and 1-year mortality (11.7%, OR 0.94). No similar improvements were seen in type 1 diabetes (incidence 1.6 per 1,000 person-years). These findings underscore advancements in primary prevention and wound care for type 2 diabetes, enabling better evaluation of DFU management efforts.

Key Highlights:

Incidence of first DFUs: 2.5 [95% CI: 2.1–2.9] per 1,000 person-years in type 2 diabetes; declined by 3% annually (IRR 0.97 [0.96–0.99]).

Type 1 diabetes showed stable incidence at 1.6 [1.3–1.9] per 1,000 person-years (IRR 0.96 [0.89–1.04]).

Hospitalization rates for type 2 diabetes averaged 8.2% [SD 4.7], with a 11% annual decline (OR 0.89 [0.84–0.94]).

One-year all-cause mortality for type 2 diabetes was 11.7% [SD 2.2], decreasing 6% annually (OR 0.94 [0.89–0.99]).

Implications: Improved primary care prevention reduces DFU burden; population data essential for ongoing wound care evaluations.

Read full article

Keywords:
diabetic foot ulcers,
DFU incidence,
type 2 diabetes,
DFU mortality,
wound prevention

Dehydrated Amnion Chorion Membrane | Superior Healing in Complex Diabetic Foot Ulcers

Dehydrated Amnion Chorion Membrane vs. Standard Care for Diabetic Foot Ulcers: RCT Results

Summary: This prospective, multicentre, randomised controlled trial evaluated dehydrated Amnion Chorion Membrane (dACM) plus standard of care (SoC) versus SoC alone in 218 patients with complex diabetic foot ulcers (DFUs) extending into dermis or deeper. Over 12 weeks, dACM significantly increased wound closure frequency (50% vs. 35% at week 12, p=0.04), with a 48% higher probability (HR 1.48) and median time to closure of 84 days versus not achieved in SoC (≥50% unhealed). Cox and Kaplan-Meier analyses confirmed benefits in this challenging population, positioning dACM as an effective adjunct for promoting granulation, reducing inflammation, and accelerating healing in chronic DFUs.

Key Highlights:

At week 12, 50% of dACM-treated DFUs achieved complete wound closure (CWC) vs. 35% in SoC, with superiority from week 4 (12% vs. 8%).

Hazard ratio of 1.48 indicated 48% greater likelihood of healing with dACM, adjusted for wound duration and area.

Median time to CWC: 84 days for dACM vs. not achieved in SoC group (p=0.04 via Kaplan-Meier).

Well-tolerated with no new safety concerns; applicable to deep, chronic DFUs in high-comorbidity patients.

Implications: dACM enhances outcomes in real-world complex cases, supporting its use beyond standard therapies.

Read full article

Keywords: dehydrated amnion chorion membrane, dACM, diabetic foot ulcers, placental allograft, wound closure RCT, Shawn M Cazzell, Joseph Caporusso, Dean Vayser

Use of Subatmospheric Pressure Systems in Diabetic Foot Ulcers

Use of Subatmospheric Pressure Systems in Diabetic Foot Ulcers

Summary: This review explores the application of subatmospheric pressure systems, or negative pressure wound therapy (NPWT), in managing diabetic foot ulcers (DFUs), a major complication of diabetes mellitus affecting millions globally due to neuropathy, vascular disease, and infection risks. Drawing from PubMed, Elsevier, and Scielo databases (2011 onward), it presents case studies demonstrating NPWT’s efficacy in accelerating healing by enhancing tissue perfusion, reducing edema and bacterial load, and stimulating granulation. At pressures of -60 to -125 mmHg, NPWT achieved 50-100% wound closure in 15-35 weeks, often with adjunct debridement and grafts, offering a non-surgical, cost-effective option that improves patient satisfaction and reduces amputation risks.

Key Highlights:

Case 1: 47-year-old woman with full-thickness DFU; NPWT at -125 mmHg reduced depth 50% by week 5, full epithelialization by week 15.

Case 2: 43-year-old woman with infected wound; NPWT at -60 to -100 mmHg enabled complete healing with skin graft.

Case 3: 34-year-old man with 3.8 cm² ulcer; NPWT at -125 mmHg with biweekly debridement achieved 91% area reduction by day 35.

Benefits: Shortens treatment duration, lowers microbial load, promotes granulation; safe with mild complications like maceration.

Implications: NPWT as adjunct/alternative to surgery for DFUs; further studies needed for first-line use in chronic wound care.

Read full article

Keywords: negative pressure wound therapy, diabetic foot ulcers, NPWT, granulation tissue, wound perfusion

Simplified and Comprehensive Diabetic Foot Ulcer Guidelines

Simplified and Comprehensive Diabetic Foot Ulcer Guidelines

Summary: March 2026 article presents simplified yet comprehensive guidelines for diabetic foot ulcer (DFU) management. Key areas: Risk stratification (IWGDF/IPAD screening), offloading (total contact casts, removable devices), debridement (sharp/autolytic), infection management (topical/systemic, biofilm disruption), vascular evaluation (ABI, toe pressures, revascularization), wound bed preparation (moisture balance, advanced dressings), patient education/adherence. Highlights multidisciplinary teams, timely referral, evidence-based advanced therapies (synthetics, biologics, NPWT). Simplified for primary care use; comprehensive for specialists. Emphasizes prevention, early intervention, and amputation reduction through standardized pathways and patient-centered care.

Read abstract (subscription may be required)

Keywords: DFU guidelines, diabetic foot ulcer, offloading, multidisciplinary DFU

The Role of Cellular, Acellular, and Matrix-like Products in Diabetic Foot Ulcer Care

Preserving Limbs and Lives: The Role of Cellular, Acellular, and Matrix-like Products in Diabetic Foot Ulcer Care

Summary: This original research article in Wounds journal evaluates the clinical impact of cellular, acellular, and matrix-like products (CAMPs) in the management of diabetic foot ulcers (DFUs). DFUs represent a leading cause of nontraumatic lower extremity amputation, and standard-of-care alone achieves complete healing in fewer than one-third of patients at 12–20 weeks. CAMPs — encompassing living cellular constructs, decellularized dermal matrices, and extracellular matrix-based scaffolds — aim to restore the disrupted wound microenvironment by providing structural scaffolding, bioactive signals, and cellular mediators that chronic DFU wound beds lack. The study’s findings indicate that CAMP utilization is associated with reduced long-term lower-limb amputation risk and improved amputation-free survival, positioning these products as a critical component of limb preservation strategy in high-risk diabetic patients. The research adds to a growing body of evidence supporting CAMPs as more than wound dressings — they are active biological interventions in the limb salvage continuum.

Key Highlights:

CAMPs associated with reduced long-term lower-limb amputation risk in DFU patients

Improved amputation-free survival compared to standard care alone

Encompasses full CAMP spectrum: cellular constructs, acellular matrices, ECM-based scaffolds

Frames CAMPs as integral to limb preservation rather than adjunctive wound dressing

Relevance: Timely given new 2026 CMS coverage and payment policies for cellular and tissue-based products (CTPs)

Read full study

Keywords: CAMPs, diabetic foot ulcer, limb preservation, acellular matrix, amputation prevention, cellular tissue products

Identifying Risk Factors Associated with the Severity of Foot Ulcers in Type 2 Diabetic Patients

Identifying Risk Factors Associated with the Severity of Foot Ulcers in Type 2 Diabetic Patients: Evidence from a Hospital-Based Study in Rajshahi, Bangladesh

Summary: This 2026 cross-sectional study of 159 type 2 diabetes patients with foot ulcers at Rajshahi Diabetic Association General Hospital (Bangladesh) found that 63.5% had severe DFU (Wagner grades 3–5). Severe cases showed higher rates of peripheral arterial disease (PAD), peripheral neuropathy (PN), poor glycemic control, prior amputation, longer ulcer duration, and greater treatment costs. Firth’s penalized logistic regression identified independent predictors: older age, poor glycemic control, PN, PAD, and prior amputation. The predictive model demonstrated strong performance (AUC 0.924, accuracy 85.5%). Findings underscore the need for early screening and aggressive management of modifiable risk factors to prevent progression to severe ulcers and reduce amputation risk in resource-limited settings.

Key Highlights:

63.5% of DFU cases were severe (Wagner 3–5); higher costs and complications in severe group

Independent risk factors: older age (aOR 1.08), poor glycemic control (aOR 3.90), PN (aOR 3.41), PAD (aOR 7.54), prior amputation (aOR 13.67)

Strong model performance with good calibration and clinical utility

Authors: Shah Tanzen Jahan, Durga H. Kutal, Anicha Akter, Md. Selim Reza, Md. Kabirul Islam, Md. Monimul Huq

Read full article (open access)

Keywords: diabetic foot ulcer severity, risk factors DFU, peripheral neuropathy, peripheral arterial disease, Shah Tanzen Jahan

Horn-Shaped Perforator Flaps for Plantar Reconstruction in Diabetic Foot Ulcers

Horn-Shaped Perforator Flaps for Plantar Reconstruction in Diabetic Foot Ulcers

Summary: This review evaluates the use of horn-shaped perforator flaps for reconstructing plantar defects after debridement of diabetic foot ulcers. The technique provides like-with-like tissue (sensate, glabrous skin) with reliable blood supply from perforators, resulting in durable weight-bearing surfaces, reduced shear forces, and lower ulcer recurrence compared to skin grafts or free flaps. The authors discuss patient selection, surgical pearls, and outcomes in high-risk diabetic populations. It represents an important reconstructive option in limb salvage algorithms for deep plantar wounds.

Key Highlights:

Horn-shaped design preserves sensation and provides robust plantar coverage

Lower recurrence rates versus traditional grafting methods

Useful in selected DFU cases after thorough debridement and vascular optimization

Read full open-access review

Keywords: perforator flap plantar, diabetic foot reconstruction, limb salvage flap

FDA Approves Shock Wave Device for Treatment of Diabetic Foot Ulcers

FDA Approves Shock Wave Device for Treatment of Diabetic Foot Ulcers

Summary: The U.S. FDA granted approval to the Dermapace System (Sanuwave Health), a noninvasive extracorporeal shock wave therapy device, for treating chronic, full-thickness diabetic foot ulcers. The device delivers focused acoustic pressure waves to stimulate wound healing through mechanical stress, angiogenesis promotion, and increased blood flow.

Key Highlights:

First shock wave device specifically approved for DFU indication

Noninvasive, office-based treatment option

Targets hard-to-heal chronic diabetic foot ulcers

Provides alternative or adjunct to standard wound care

Read full article

Keywords: shock wave therapy DFU, Dermapace, extracorporeal shock wave

STEADY Diabetic Foot Ulcer Registry: Methods, Insights, and Future Directions

STEADY Diabetic Foot Ulcer Registry: Methods, Insights, and Future Directions

Summary: This original research presents the methodology and initial findings from the STEADY Diabetic Foot Ulcer Registry. The prospective, multicenter registry collects real-world data on DFU patients to better understand treatment patterns, outcomes, and opportunities to improve healing rates and reduce amputations through evidence-based insights.

Key Highlights:

Prospective, real-world DFU registry design

Focus on treatment effectiveness and patient outcomes

Early insights into current clinical practice gaps

Framework for future quality improvement and research

Read full original research

Keywords: STEADY DFU registry, diabetic foot ulcer registry, real world DFU data

Diabetic foot ulcer treatment could kill COVID-19 virus, researchers say

A new foot ulcer formulation developed by scientists at the University of South Australia could be used to kill the COVID-19 virus, according to new research.

In a study published in the journal Applied Physics Letters, the team looked at the treatment of antimicrobial-resistant bacterial infections, experimenting to find an effective non-antibiotic antimicrobial strategy to combat the infections in diabetic foot ulcers.

The authors found that enhancing cold plasma ionized gas with peracetic acid was “highly effective” at eradicating common wound pathogenic bacteria and at inactivating SARS-Cov-2 … read more

Diabetes-related Retinopathy, Foot Ulcers, and Other Lesions

Diabetes-related Retinopathy, Foot Ulcers, and Other Lesions: A Photo Essay

Summary: This educational photo essay presents clinical images of diabetes-related complications, with a strong focus on foot ulcers alongside retinopathy and other lesions. Cases demonstrate neuropathic ulcers linked to structural deformities (hammer toes, Charcot neuroarthropathy), callus formation, and the need for debridement of necrotic, calloused, and fibrous tissue. It covers application of topical enzymes, special dressings, and offloading strategies. Visuals highlight progression risks and the importance of prompt multidisciplinary care involving podiatry, vascular assessment, and glycemic control to prevent amputation. Serves as a practical teaching resource for recognizing and managing diabetic foot disease in clinical settings.

Key Highlights:

Visual cases of diabetic foot ulcers, Charcot foot, and related lesions

Emphasis on debridement, dressings, and offloading techniques

Links retinopathy and systemic complications to foot disease

Relevance: Strong educational tool for diabetic wound recognition and management

View photo essay

Keywords: diabetic foot ulcers, photo essay, Charcot foot, debridement

SIGNS OF WOUND INFECTION THAT EVERYONE SHOULD KNOW

Wound infection is such a common condition and presents so often that every wound care professional will recognize the major signs and symptoms almost instantly. However, the consequences of diagnosing wound infection late, or missing the signs of wound infection completely, are such that it is worth spending a few moments every now and again to remind ourselves of all the signs of wound infection.

As we are taught during training, the principal signs of wound infection are rubor, calor, tumor, functio laesa, drainage, and a decline in wound status. Rubor in an infected wound describes a poorly defined erythemal border with a disproportionate amount of erythema, while calor describes a magnified localized increase in temperature with warmth extending further away from the site and a possible systemic increase in body temperature … read more

How the Identification of Chronic Wound Infection Can Be Improved With Technology

by Liping Tang

Infection is the single most likely cause of delayed healing in chronic wounds. In most cases, identification of chronic wound infection (e.g., diabetic foot ulcers and venous leg ulcers) is not obvious because chronic wounds do not exhibit the same classic inflammatory signs of infection as those found in acute wounds. More arduously, those common signs of infection—pain, erythema, heat, and purulent exudate— vary as we age and occur differently in those with underlying diseases or weakened immune systems. Diagnosis is generally based on the doctors’ experience and could be confirmed with microbiological culture of tissue biopsy. However, culture could take a few days, and the results may not always be reliable because of sampling error. A fast and accurate diagnosis of wound infection would relieve the patient of significant discomfort and improve the treatment outcome … read more

Smart wound monitor poised to improve chronic infection care

‘Smart Wound Patch’ Poised to Detect and Prevent Chronic Infection

Researchers at the University of Rhode Island have developed a prototype smart wound patch that detects early signs of infection in chronic wounds—offering a potential game-changer in preventing complications like sepsis or amputation.

The flexible, bandage-like patch uses integrated sensors to monitor biomarkers in wound fluid, including pH and temperature changes. These early shifts often indicate the onset of bacterial infection or delayed healing.

Key Features:

Non-invasive, continuous monitoring: The patch uses real-time biosensors to detect wound changes without disturbing the dressing.

Wireless data transmission: Results can be sent to a smartphone or clinician dashboard, enabling timely intervention.

Early warning capability: By catching inflammatory trends before visible symptoms arise, it may help clinicians avoid more invasive treatments.

The lead researcher, Kunal Mankodiya, PhD, director of the Wearable Biosensing Lab at URI, envisions applications in diabetic foot ulcers, surgical wounds, and pressure injuries—where early detection of infection is critical to preventing chronicity and escalation.

Clinical Implications: With further testing and development, smart wound technologies like this could reduce hospitalizations, improve outcomes in hard-to-heal wounds, and decrease long-term care costs. The team is working toward FDA approval and future commercial deployment.

Keywords: Kunal Mankodiya, smart wound patch, chronic wounds, infection detection, wearable biosensors, University of Rhode Island

Read the full article at Medical Xpress

Bacteria Suppress Immune Defenses in Wound Infections

Bacteria Suppress Immune Defenses in Wound Infections

Summary: Researchers from the Singapore-MIT Alliance for Research and Technology (SMART) AMR group discovered that Enterococcus faecalis, a common bacterium in chronic wounds, releases lactic acid to suppress macrophage activation and immune response. Lactic acid enters macrophages through the MCT-1 transporter and binds the GPR81 receptor, blocking downstream NF-κB signaling and preventing effective inflammation and bacterial clearance. In mouse wound models, lactic acid-deficient E. faecalis strains were cleared faster with stronger immune activity. The mechanism also facilitates co-infection with other bacteria like E. coli, explaining why polymicrobial infections in diabetic foot ulcers and other chronic wounds are persistent and difficult to treat. The findings suggest new therapeutic strategies focused on neutralizing acidity or restoring immune function rather than antibiotics alone.

Key Highlights:

E. faecalis lactic acid inhibits macrophage activation via MCT-1 and GPR81

Blocks NF-κB signaling, allowing persistent and polymicrobial wound infections

Stronger immune clearance when lactic acid production is absent in mouse models

Implications for chronic wounds including DFU and post-surgical infections

Read full article

Keywords: Enterococcus faecalis, lactic acid wounds, macrophage suppression, polymicrobial infections

Effects of Simultaneous versus Staged VAC Placement in the Treatment of Deep Neck Multiple-Space Infections at a …

Tertiary Hospital Over a Four-Year Period in China

Deep neck infections (DNIs) are a group of serious bacterial infections occurring in the potential spaces and fascia of the neck. The incidence of DNIs is not clear. Although many studies have shown that the incidence of DNIs has decreased due to the use of antibiotics and improvements in sanitary conditions, reports also indicate an increased incidence of DNIs in the last 10 years. Deep neck multiple-space infections (DNMIs) are the most serious among all types of DNIs and often spread further to cause mediastinal infections, invade the carotid sheath, and possibly compromise the airway, resulting in life-threatening conditions.

Treatments for DNMIs include life-supporting measures, surgical drainage, and appropriate use of antibiotics. Among these treatments, surgical drainage is key. Although traditional extensive surgical drainage is effective for treating DNMIs, some limitations remain for this approach, ie, drainage depends on gravity, the locations for the drainage tube and incision are limited, dressing changes and wound irrigation more than once a day may increase patient suffering, and secondary wound infection may occur. In recent years, vacuum-assisted closure (VAC)

To Conquer or Be Defeated: The Strategy Behind Winning the Wound Infection Battle | webinar

Wound infection has a significant impact on wound healing potential. When managing a wound, the first step is to determine if you are looking at an acute or chronic wound infection. Acute wound infection can be devastating and is often an underappreciated clinical condition that has been reported to increase the cost of care by up to 70%. Chronic wound infections are microbiologically, immunologically, and clinically distinct from acute wound infections and require a different treatment strategy … register

Preventing Surgical Wound Infections: Key Nursing Interventions

Preventing Surgical Wound Infections: Key Nursing Interventions

Summary: A recent blog post on WoundSource highlights essential nursing interventions to prevent surgical incision infections, emphasizing early attention, meticulous hygiene, and post-operative wound care.

Key Highlights:

Hands and forearms should be washed thoroughly with antiseptic soap and a nail brush for at least five minutes before contact with the incision.

Strict hand hygiene and aseptic technique are critical in minimizing the risk of introducing bacteria during dressing changes and wound care.

Effective nursing strategies include early identification of high-risk patients, ongoing inspection for subtle signs of infection, and prompt intervention when abnormalities arise.

Continuity of care—especially during handoffs between surgical and post-op teams—ensures consistent infection prevention practices.

Read the full post on WoundSource

Keywords:
surgical wound infections,
nursing interventions,
hand hygiene,
aseptic technique

MolecuLight Featured in Vizient Tech Watch as Key Technology for Visualizing Bacterial Burden

and Helping to Reduce Surgical Site Infections

Article is a Follow-On to MolecuLight’s Receipt an Innovative Technology Contract from Vizient Last Year

PITTSBURGH, Dec. 6, 2022 /PRNewswire/ – MolecuLight Corp., the leader in point-of-care fluorescence imaging for detection of wounds containing elevated bacterial loads, is featured in Vizient’s newly released Tech Watch publication as a key technology for visualizing bacterial load and its locations, and helping to reduce surgical site infections. The article, “Fluorescence Imaging: New technology enables point-of-care surgical wound bacterial assessment” is featured in Vizient’s Tech Watch (Medical Device) Volume 3 issue, issued this past week.

MolecuLightDX™ point-of-care Imaging device to detect elevated bacterial loads in wounds to help clinicians prevent surgical site complications. (CNW Group/MolecuLight)

The Tech Watch article describes how surgical site infections (SSIs) occur in up to 38% of surgeries1 (depending on anatomical location and type of surgery) and account for 20% of all healthcare-acquired infections2. SSIs are also the costliest of these infections, extending the average length of hospital stays by 9.7 days and costing more than $20,000 per patient admission3,4.

Early and accurate diagnosis of post-surgical bacterial loads and infection is critical to enable prompt treatment before the infection worsens. Some cases require lab testing to accurately diagnose the bacteria colonizing the wound, allowing the offending bacteria to grow and spread and delay effective treatments. Test results can take days to weeks to be available and, if positive, could be too late to prevent infection.

Clinicians need real-time diagnostic tools that they can use at the point-of-care to help provide immediate information on the state of the wound and possible growth of bacterial burden. The article argues that MolecuLight imaging helps eliminate unnecessary subjectivity in assessing wounds for the presence of harmful bacteria by allowing quick and accurate visualization of locations of elevated bacteria load in wounds, along with clinical signs and symptoms. As such, it provides “invaluable real-time information to inform clinical decision-making”.

A recent per-reviewed study5 supports this position in demonstrating the benefits of using MolecuLight to help clinician visualize bacterial burden in surgical site wounds:

76% of surgical sites in the study that reach the stage of referral to a wound specialist had clinically significant bacterial loads (10⁴ to 10⁹ CFU/g), however only 6.8% exhibited symptoms of infection, resulting in delayed infection management.

Point-of-care fluorescence imaging (using the MolecuLight i:X device) for detecting high bacterial loads improved sensitivity by 5.7-fold compared to clinical signs and symptoms alone.

Clinician experience with fluorescence imaging and interpretation (>200 imaging sessions) increased sensitivity of fluorescence imaging to 11.3-fold higher than clinical signs and symptoms alone, and accuracy to 2.6-fold higher.

“Clinicians need an objective means of detecting infection or another surgical wound complication without having to rely on subjective judgment,” says Kylie Sandy-Hodgetts, PhD, Founder and inaugural President of the International Surgical Wound Complications Advisory Panel (ISWCAP).

“Fluorescence imaging using MolecuLight is positioned to change contemporary paradigms of post-surgical wound management due to its ability to quickly and reliably detect bacterial burden and visualize contamination at the point-of-care”.

In addition to the profile in Vizent’s Tech Watch, last year the MolecuLight i:X® fluorescence wound imaging device received an Innovative Technology contract from Vizient, Inc., the nations’ largest member-driven health care performance improvement company. The new Innovative Technology contract for MolecuLight i:X signifies to Vizient members the device’s unique qualities that potentially bring improvement to the health care industry.

“We have been working with MolecuLight since 2021 when Vizient recognized the company as an awarded supplier through our Innovative Technology Program,” said Tami Maurer, VP, Contract & Program Services at Vizient, Inc. “Carefully evaluated and selected by our member council of clinical and supply chain professionals, Vizient’s Innovative Technology Program recognizes innovative advancements in care, enabling healthcare providers to offer the highest quality care while encouraging manufacturers to continue to pioneer new solutions.”

The MolecuLight i:X and DX are the only imaging devices for the real-time detection of elevated bacterial burden in wounds that are FDA cleared and CE and Health Canada approved. With clinical evidence including over 60 peer-reviewed publications involving 1,500 patients, they are used by leading wound care facilities globally.

About MolecuLight Corp.

MolecuLight Corp. is the US subsidiary of MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight ‘s suite of commercial devices, which include the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, are point-of-care handheld imaging devices for the real-time detection and localization of bacterial load in wounds and digital wound measurement. MolecuLight procedures performed in the United States benefit from an available reimbursement pathway which includes two CPT® codes for physician work to perform “fluorescence imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. The company is also commercializing its unique fluorescence imaging platform technology for other global markets with relevant unmet needs in food safety, consumer cosmetics and other key industrial markets.

This article was originally published here

Caring for the diabetic foot

Patients with psoriasis have a higher risk of developing new onset diabetes mellitus. It’s a risk that’s been described as statistically significant. So, in this article, we examine dermatologic care for diabetic foot infections.

Patients with psoriasis have a higher risk of developing new onset diabetes mellitus. The increased incidence of psoriasis and diabetes mellitus was documented in a 2013 study by Usman Khalid, et al. published in Diabetes Care in which authors described the correlation as “statistically significant.” So, in this article, we examine dermatologic care for diabetic foot infections.

Dermatologists must be able to diagnose and manage mild-to-moderate infections in diabetic foot ulcers (DFUs), said Warren S. Joseph, D.P.M., FIDSA, in a presentation at DERMfoot 2018 in Baltimore … read more

Barriers to Prevention and Timely Presentation of Diabetic Foot Ulcers: Perspectives of Patients from a High-risk Urban Population in the US

Diabetic foot amputation is a preventable complication that is increasing in incidence in the United States, with disparities across geography, race, ethnicity, and income. This qualitative study explored the experiences of people in a low-income urban area in the United States in preventing and obtaining care for foot ulcers. Sixteen adults with foot ulcers were identified through purposive sampling based on records of hospital stays and primary care visits. Semi-structured interviews were transcribed and analyzed for key themes. Participants described inadequate understanding of diabetic foot disease: many sought care only after developing advanced symptoms. They identified social and health system factors as barriers to timely access to care. Some participants described a realization of the seriousness of their condition and an ability to improve self-care after developing an ulcer. Patients’ experiences can inform the design of amputation-reduction initiatives to achieve more desirable results, including enhanced self-management capabilities, timely access, and attention to social determinants … read more

To Train or not to Train: Exercise in Diabetic Foot Ulceration

Exercise in Diabetic Foot Ulceration: A Brief Narrative Review

Published recently in *Integrative Medicine, A Clinical Journal* (via SAGE), this narrative review examines the role of exercise in diabetic foot ulcer (DFU) management, emphasizing benefits for glycemic control, neuropathic symptom relief, and overall well-being.

Key Insights:

Glycemic Benefits: Regular physical activity supports glucose regulation and cardiovascular health—both critical to wound healing in diabetes.

Neuropathy Management: Exercise may help reduce neuropathic symptoms like pain, tingling, or numbness, potentially improving foot sensation and awareness.

Mental Health Advantage: Improved physical fitness can alleviate stress and anxiety, which are known to adversely affect wound recovery.

Holistic Approach: Combined with standard DFU care—offloading, infection control, and debridement—exercise supports overall patient resilience and could reduce recurrence risk.

While acknowledging the need for caution in neuropathic feet, the authors advocate incorporating tailored exercise plans—under supervision—as a multi-dimensional strategy in DFU management.

Keywords:
exercise therapy,
diabetic foot ulcer,
glycemic control,
neuropathy,
mental well-being

Read the full review on SAGE Journals

Patients With Infected Diabetic Foot Ulcers Need Quick Referral

Patients with an infected diabetic foot ulcer have a far worse prognosis than previously thought, with 15% of patients dying within a year, less than half of the ulcers healing in the same time period, and one in seven individuals having all or part of their foot amputated, results from a new UK study reveal.

The analysis of almost 300 patients with infected diabetic foot ulcers also showed that, even if the ulcer healed, nearly 10% experienced a recurrence within 12 months and more than 25% of patients underwent some kind of procedure.

It’s therefore crucial that such patients are reviewed quickly and referred for specialist care if required, say Mwidimi Ndosi, PhD, of the University of West Bristol, United Kingdom, and colleagues in their paper published online November 20 in Diabetic Medicine … read more (registration required)

HbA1c, wound healing unrelated in diabetic foot ulcers

Among patients with long-term diabetic foot ulcers, neither baseline HbA1c nor change in HbA1c was associated with wound healing time, according to findings from a clinic-based observational study.

“Although we know that chronic hyperglycemia leads to neuropathy and peripheral vascular disease, which are the proximal risk factors for diabetic foot ulcers, we did not see a clear association between HbA1c levels and wound healing in patients who have developed foot ulcers,” Nestoras Mathioudakis, MD, MHS, assistant professor of medicine and clinical director, division of endocrinology, diabetes and metabolism at Johns Hopkins University School of Medicine, told Endocrine Today. “It is likely that the damage induced by chronic hyperglycemia reaches a point where it cannot be reversed in a relatively short time frame to improve wound healing.”

read more

Health Equity podcast #6: Preventing diabetic foot ulcers

In this episode, we are joined by Dr. Ernest Moy, Executive Director of the Office of Health Equity and Dr. Jeffrey Robbins, director of VA Central Office Podiatry Service. Also participating is Suzanne Shirley, director of Partnerships and Community Engagement with the VA Innovation Ecosystem.

Do you know why it is so crucial to address diabetic foot ulcers?

Moy discusses differences in Veterans affected by diabetic foot ulcers and why this program to manage and reduce foot ulcers can improve the health of our Veterans.
… listen

Amputation risk up for Black, rural residents with diabetic foot ulcers

Rural patients identifying as Black have more than a 10 percent absolute increased risk for major leg amputation or death compared with the overall cohort of adult Medicare patients hospitalized with a diabetic foot ulcer, according to a study published online April 21 in JAMA Network Open … Meghan B. Brennan, M.D., from the University of Wisconsin in Madison, and colleagues examined the associations of race, ethnicity, rurality, and/or neighborhood disadvantage with outcomes among U.S. patients with diabetic foot ulcers. The analysis included 124,487 patients hospitalized with diabetic foot ulcers (2013 to 2014) identified through the U.S. National Medicare Claims Data Database … read more

Advancements in diabetic foot ulcer research

Advancements in Diabetic Foot Ulcer Research, published in Heliyon in 2024, offers a comprehensive overview of current treatment strategies for diabetic foot ulcers (DFUs). It systematically compares various therapeutic approaches, highlighting their respective advantages and limitations.

ShuHui Wu, ZhongSheng Zhou, Yang Li, Jinlan Jiang

Key Highlights:

Treatment Modalities: The article examines a range of treatments, including wound dressings, negative pressure wound therapy, hyperbaric oxygen therapy, and advanced therapies like stem cell applications.

Advantages and Limitations: Each treatment is assessed for its efficacy, accessibility, cost-effectiveness, and potential side effects. For instance, while hyperbaric oxygen therapy shows promise in enhancing wound healing, it may not be widely accessible due to cost and equipment requirements.ScienceDirect

Clinical Implications: The review underscores the importance of personalized treatment plans, considering patient-specific factors such as comorbidities, ulcer severity, and resource availability.

This article serves as a valuable resource for healthcare professionals seeking to understand the evolving landscape of DFU management and emphasizes the need for continued research to optimize patient outcomes.ScienceDirect

For a more in-depth understanding, you can access the full article here: ScienceDirect.

Keywords
Diabetic foot ulcers, Mesenchymal stem cells, Exosomes

Millions of people with diabetic foot ulcers could benefit from new research discovery

Insulin and Metformin Synergy May Accelerate Diabetic Foot Ulcer Healing

Researchers from Michigan State University and South Shore Hospital have uncovered a potential synergistic effect between two common diabetes medications—insulin and metformin—that may enhance the healing of diabetic foot ulcers (DFUs). Their study, published in ACS Pharmacology and Translational Science, analyzed wound exudate from patients with DFUs and discovered the presence of metformin in the wound fluid of those taking the drug orally. Notably, patients concurrently using insulin injections exhibited significantly higher levels of metformin at the wound site.

Key Findings:

Metformin was detected in the wound exudate of patients taking the drug orally.

Patients using both insulin and metformin had increased concentrations of metformin at the wound site.

This interaction suggests a previously unrecognized synergy between insulin and metformin in promoting wound healing.

These findings could have immediate implications for clinicians treating chronic wounds and for developers of advanced wound dressings. The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

Read the full article on the EurekAlert! website.

Keywords:
Diabetic foot ulcers,
Insulin,
Metformin,
Wound healing,
Morteza Mahmoudi,
Lisa Gould

Webinar: Diabetic Foot Ulcer Charting the Depths With Intact Fish Skin

Diabetic Foot Ulcer: Charting the Depths With Intact Fish Skin

Join us for an insightful webinar exploring the early management of diabetic foot ulcers (DFUs) using intact fish skin grafts. This session delves into the genesis and application of this innovative treatment, offering a comprehensive overview of its role in wound care.

Webinar Details:

Date: Tuesday, June 10, 2025

Time: 12:00 PM EDT

Presenter: John Lantis, II MD, FACS

Dr. Lantis will share his expertise on the utilization of intact fish skin grafts in managing DFUs, discussing clinical experiences and outcomes. Attendees will gain valuable insights into this emerging therapy and its potential benefits in wound healing.

Register for the webinar on the Podiatry.com website.

Keywords:
Diabetic foot ulcer,
Intact fish skin graft,
John Lantis,
DFU management

Time in Range as a Predictor of Diabetic Foot Ulcer Healing

Time in Range as a Predictor of Diabetic Foot Ulcer Healing

A prospective study reported on June 16, 2025, in DiabeticFootOnline.com highlights the use of continuous glucose monitoring (CGM)–derived Time in Range (TIR) as a valuable predictor of healing time in patients with non-complicated diabetic foot ulcers (DFUs, grade I–II, stage A–C).

Key Highlights:

Strong Correlation with Healing: Higher TIR (blood glucose within target range) was significantly associated with faster DFU healing (p = 0.005), while elevated Time Above Range and Glucose Management Indicator correlated with slower wound closure (p < 0.05). :contentReference[oaicite:1]{index=1}

Real-world Application: Patients wore CGM devices from baseline until complete wound closure under standard outpatient care, demonstrating TIR’s practical value in routine clinical settings. :contentReference[oaicite:2]{index=2}

Glycemic Control Matters: Findings support the concept that maintaining optimal glycemic stability via CGM can directly influence wound healing outcomes in DFUs. :contentReference[oaicite:3]{index=3}

These results reinforce growing evidence—such as the PubMed-listed study in *Wound Repair and Regeneration* (May–June 2025)—that TIR is a reliable biomarker for predicting DFU healing time in type 2 diabetes. :contentReference[oaicite:4]{index=4}

Read the full article on DiabeticFootOnline.com.

Keywords:
Time in Range,
continuous glucose monitoring,
diabetic foot ulcer,
wound healing,
glycemic control

Ischemia Modified Albumin in Diabetic Foot Ulcers: Promising Marker or Incomplete Picture?

Ischemia-Modified Albumin in Diabetic Foot Ulcers: Promising Marker or Incomplete Picture?

Summary: A letter by **Seshadri Reddy Varikasuvu, PhD** (AIIMS, Deoghar) published in *International Journal of Lower Extremity Wounds* (ahead of print, August 2025) critically examines a study by Juttada et al. that explored serial monitoring of ischemia-modified albumin (IMA) as a biomarker for healing in diabetic foot ulcers (DFUs).

Key Reflections:

Varikasuvu acknowledges the novelty of using serial IMA measurements to reflect wound healing dynamics.

However, he raises concerns about the study’s predictive validity, noting limitations such as inadequate adjustment for baseline albumin levels and neglect of oxidative therapies like hyperbaric oxygen therapy.

The letter recommends that future biomarker research in DFUs should adopt a multi-marker strategy and account for oxidative stress variability to strengthen clinical utility.

Read the full letter in *International Journal of Lower Extremity Wounds*

Keywords:
ischemia-modified albumin (IMA),
diabetic foot ulcer,
biomarkers,
oxidative stress,
hyperbaric oxygen therapy,
wound healing monitoring

Exploring the Role of GLP-1 Agents in Managing Diabetic Foot Ulcers

Exploring the Role of GLP-1 Agents in Managing Diabetic Foot Ulcers: A Narrative and Systematic Review

Summary: A narrative and systematic review published in Wound Repair & Regeneration (Sep–Oct 2025) by Fiona S. Gruzmark, Gabriela E. Beraja, Ivan Jozic, and Hadar A. Lev-Tov explores the emerging potential of systemic GLP-1 receptor agonists (commonly used in diabetes and weight loss) to support healing in diabetic foot ulcers (DFUs).

Key Highlights:

DLRUs are a major global health burden—DFU incidence ranges from ~19% to 34%, with a 10% one-year mortality rate after ulcer diagnosis.

GLP-1 receptor agonists have shown beneficial effects in related dermatologic conditions (e.g., alopecia, hidradenitis suppurativa), suggesting a broader regenerative or anti-inflammatory role.

The review integrates narrative insights with a PRISMA-guided systematic search, noting potential reductions in DFU complications associated with GLP-1 use.

This represents a promising therapeutic avenue—targeting multiple pathophysiologic domains (microvascular health, neuropathy, apoptosis, oxidative stress)—but requires clinical trials to confirm efficacy.

Read the full review in Wound Repair & Regeneration

Keywords:
GLP-1 agents,
diabetic foot ulcer,
systematic review,
narrative review,
wound healing
Fiona S. Gruzmark,
Gabriela E. Beraja,
Ivan Jozic,
Hadar A. Lev-Tov

Dehydrated Amnion-Chorion Membrane vs Standard of Care for Diabetic Foot Ulcers

Dehydrated Amnion-Chorion Membrane vs Standard of Care for Diabetic Foot Ulcers: A Randomized Controlled Trial

Summary: A prospective, multicentre RCT published in 2024 by **Shawn M. Cazzell**, **Joseph [last name?]**, **Robert D. D. [last name?]**, **OMA [initials?]**, and **M. L. Sabolinski** compared the efficacy of dehydrated amnion-chorion membrane (dACM) plus standard of care (SoC) versus SoC alone in treating complex diabetic foot ulcers (DFUs) extending into dermis, tendon, or bone, over 12 weeks.

Key Highlights:

The dACM group had significantly higher closure rates at weeks 4 (12% vs 8%), 6 (22% vs 11%), 8 (31% vs 21%), 10 (42% vs 27%), and 12 (50% vs 35%).

Patients in the dACM arm had a 48% greater probability of closure (hazard ratio 1.48; 95% CI: 0.95–2.29; p = 0.04).

Median time to complete wound closure was 84 days with dACM, while half of the SoC group had not healed by week 12.

The study population (218 patients total, 109 per arm) consisted of complex, chronic DFUs, demonstrating the trial’s real-world relevance.

Read the study abstract on PubMed

Keywords:
dACM,
dehydrated amnion-chorion membrane,
diabetic foot ulcer,
randomized controlled trial,
Shawn M. Cazzell,
M. L. Sabolinski

High Relapse Risk in Diabetic Foot Ulcers

High Relapse Risk in Diabetic Foot Ulcers

Summary: A Medscape view article published in 2025 highlights striking new data showing that diabetic foot ulcers (DFUs) carry relapse risks at levels that match or exceed those of aggressive cancers. By pulling together recent studies on ulcer recurrence and limb preservation, the authors call for more vigilant follow-up and structured surveillance after remission.

Key Highlights:

At 3 years after healing (remission), approximately **58%** of patients with DFUs experience recurrence.

Similarly, about **50%** of patients who had chronic limb-threatening ischemia (CLTI) treated via endovascular intervention require reintervention within 3 years.

Those relapse and reintervention rates are comparable to—or even higher than—those for many advanced cancers such as breast, colorectal, or prostate when considering a 3-year window.

These findings underscore that “healed” DFUs should not be treated as endpoints but signals for ongoing risk; patients in remission need structured monitoring similar to post-cancer care protocols.

Read the full article on Medscape

Keywords:
diabetic foot ulcer recurrence,
chronic limb-threatening ischemia (CLTI),
relapse risk,
three-year rate

Silent and Sinister: High Prevalence of Silent, Severe Coronary Ischemia in Patients with Diabetic Foot Ulcers

Silent and Sinister: High Prevalence of Silent, Severe Coronary Ischemia in Patients with Diabetic Foot Ulcers

Summary: A recent study published in *Journal of Vascular Surgery* (Monahan et al., 2025) found that a large portion of patients with diabetic foot ulcers (DFUs), even without prior known coronary artery disease or symptoms, have **silent but severe coronary ischemia** detectable on advanced imaging. This suggests underrecognized cardiovascular risk in the DFU population and possible need to integrate cardiac screening into comprehensive care.

Key Highlights:

Among selected DFU patients who underwent coronary CT angiography (cCTA), more than half showed functional evidence of severe coronary disease via CT-derived fractional flow reserve (FFRct ≤ 0.75).

Some patients required coronary intervention following catheterization despite no history of cardiac disease or symptoms.

Suggests that DFU should be treated not only as a local wound issue but as a marker of systemic vascular disease.

Read the full article on DiabeticFootOnline

Keywords:
diabetic foot ulcer,
coronary ischemia,
silent ischemia,
CT-angiography,
Monahan et al.,
vascular risk

Association of Inflammation and Nutrition-Based Indicators With Diabetic Foot Ulcers

Association of Inflammation and Nutrition-Based Indicators With Diabetic Foot Ulcers

Summary: A new combined cross-sectional and retrospective study from China (Hua Chen, Yu Zhou, Jiezhi Dai) examines multiple inflammation and nutrition biomarkers and their association with prevalence of diabetic foot ulcers (DFUs). Using a large US dataset (NHANES) plus a clinical retrospective arm, the team finds strong links between DFU presence and indicators such as neutrophil-albumin, monocyte-albumin, red cell distribution width-albumin, HALP, and PNI.

Key Highlights:

Data from ~31,126 participants in NHANES (1999–2004) and clinical data comparing DFU vs non-DFU patients.

Higher tertiles of NAR, MAR, and RAR (ratios combining inflammatory cells or red-cell width with albumin) correlate with increased odds of DFU.

Higher HALP (hemoglobin-albumin-lymphocyte-platelet) and Prognostic Nutritional Index (PNI) are inversely correlated with DFU – i.e. better nutrition/inflammation status associated with lower DFU risk.

Non-linear relationships found, especially for RAR, showing risk climbs sharply at higher levels.

Read the full article in Frontiers in Endocrinology

Keywords:
inflammation biomarkers,
nutrition indices,
diabetic foot ulcer prevalence,
NHANES,
Hua Chen,
Yu Zhou,
Jiezhi Dai

Umbrella Review: Traditional Chinese Medicine Improves Outcomes in Diabetic Foot Ulcers

Umbrella Review: Traditional Chinese Medicine Improves Outcomes in Diabetic Foot Ulcers

Summary: A recent umbrella review published in Frontiers in Medicine assessed meta-analyses on Traditional Chinese Medicine (TCM) as adjunctive therapy for diabetic foot ulcers (DFUs). It finds that TCM interventions—especially topical/herbal formulations—are associated with improved healing outcomes and reduced complications, especially when treatments are applied over longer durations and in larger samples.

Key Highlights:

Herbal treatments, ointments, and topical TCM formulations showed benefit in terms of wound size reduction, faster granulation, and fewer adverse events.

Effect magnitudes tended to be higher when studies had longer follow-ups or more rigorous design quality.

Safety was generally acceptable; some studies reported mild local irritation, but serious harms were rare.

Review authors call for better standardization of herbal product preparation, ingredient quality, outcome metrics, and blinding in trials.

Read the umbrella review in Frontiers in Medicine

Keywords:
Traditional Chinese Medicine,
diabetic foot ulcer,
herbal formulations,
adjunct therapy,
recovery times

Knowledge, Attitude & Behaviour Toward Diabetic Foot Ulcers in East Java Community

Knowledge, Attitude & Behaviour Toward Diabetic Foot Ulcers in East Java Community

Summary: A cross-sectional study conducted at Haji Regional General Hospital, East Java Province, Indonesia, assessed the community’s knowledge, attitude, and behaviour concerning diabetic foot ulcers (DFU). While many respondents had good attitudes, knowledge and behaviour/practice were frequently poor. The study found that knowledge level was not significantly associated with DFU occurrence, but attitude and behaviour/practice showed significant correlations.

Key Highlights:

Poor knowledge common: 39.7% of respondents demonstrated poor knowledge about DFUs.

Mixed attitude: 52.9% of respondents showed a good attitude toward prevention, despite gaps in knowledge and practice.

Poor practices pervasive: Over half (52.9%) had poor behaviour/practice in preventive care for DFUs.

Knowledge vs outcome: No statistically significant association between knowledge level and occurrence of DFU.

Attitude & behaviour matter: Attitude and practice/behaviour were significantly associated with DFU presence.

Read the full study in IJSRM

Keywords:
diabetic foot ulcer,
knowledge,
attitude,
behaviour,
prevention practices,
East Java

The Role of Conjunctive Hyperbaric Oxygen Therapy in Decreasing Amputations in those with Diabetic Foot Ulcers

The Role of Conjunctive Hyperbaric Oxygen Therapy in Decreasing Amputations in those with Diabetic Foot Ulcers: A Clinical Review

Summary: This clinical review appraises published evidence on the adjunctive use of hyperbaric oxygen therapy (HBOT) in diabetic foot ulcers (DFUs) and its impact on reducing major amputations and enhancing healing. Incorporating six comparative studies, the review synthesizes outcomes on wound size, infection, amputation rates, and mortality.

Key Highlights:

HBOT as an adjunct to standard wound care demonstrated superior healing and reduced amputation in chronic DFUs.

Meta-analyses included show consistent trends favoring HBOT over conventional therapy alone.

The review process included filters, MeSH terms, and strict inclusion criteria to narrow to six high-quality studies.

Authors call for larger prospective trials to better quantify risks, benefits, and optimal protocols.

Read full article

Keywords:
hyperbaric oxygen therapy,
diabetic foot ulcer,
amputation risk,
wound healing,
adjunctive therapy

Advanced MRI Markers: Predicting Diabetic Foot Ulcer Healing

Advanced MRI Markers: Predicting Diabetic Foot Ulcer Healing

Summary: Presented at the American Diabetes Association Scientific Sessions, this prospective observational study from Emory University explores noncontrast MRI perfusion imaging to forecast diabetic foot ulcer (DFU) healing. In 17 patients with chronic plantar forefoot ulcers, the technique measured resting tissue perfusion and microvascular reactivity using a dynamic cuff-occlusion method. Over 12 weeks, 47% of ulcers healed, with non-healers showing elevated resting perfusion but impaired microvascular function—such as delayed time-to-peak hyperemia (171 seconds vs. 101 seconds) and reduced tissue oxygen reserve (-6.5% vs. -3.2%). These findings suggest MRI markers could enhance prognostic accuracy, guiding targeted interventions to prevent amputations in cases where standard vascular assessments fall short, leaving 1 in 6 patients with unresolved wounds after a year.

Key Highlights:

Noncontrast MRI revealed microvascular deficiencies in non-healers despite adequate macrocirculation, aligning with clinical challenges in DFU management.

Healing occurred in 47% of chronic ulcers over 12 weeks, emphasizing the need for better predictive tools in limb preservation.

Key metric: Time-to-peak hyperemia was markedly longer in non-healers (171s vs. 101s), indicating poorer reactive hyperemia for tissue repair.

Tissue oxygen reserve capacity trended lower in non-healers (-6.5% vs. -3.2%), highlighting MRI’s potential to assess functional perfusion.

Ongoing research integrates these markers with clinical data for refined models, promising personalized strategies to reduce amputation risks.

Read full article

Keywords:
diabetic foot ulcers,
MRI perfusion imaging,
microvascular reactivity,
DFU healing prediction,
limb preservation

blaSHV Genes in Bacteria Among Diabetic Foot Ulcer Patients from Selected Referral Hospitals in Uganda

blaSHV Genes in Bacteria Among Diabetic Foot Ulcer Patients from Selected Referral Hospitals in Uganda

Summary: This cross-sectional study at 7 Ugandan hospitals analyzed 117 diabetic foot ulcer (DFU) patients, finding 105 (89.7%) positive for bacterial growth, predominantly Gram-negative (E. coli, Klebsiella). ESBL production was 37.1% (39/105), with blaSHV genes in 71.8% of ESBL isolates, driving high resistance to cephalosporins (90%) and amoxicillin (95%). Gram-positives like S. aureus showed MRSA at 20%. The findings underscore the need for routine ESBL screening, antibiotic stewardship, and surveillance in DFU management to curb infection-driven amputations in low-resource settings.

Key Highlights:

Demographics: 117 patients (mean age 58 years, 58% male); 105 cultures positive, 70% Gram-negative.

ESBL Prevalence: 37.1%; blaSHV (28/39), blaTEM (24/39); multi-drug resistance in 82% ESBL producers.

Resistance Patterns: 90% to 3rd-gen cephalosporins; 95% to amoxicillin; carbapenems effective (85%).

Site Variation: Higher ESBL in urban hospitals (Kiruddu 50%, Fort Portal 46%); S. aureus in 30%.

Implications: Urgent stewardship; molecular surveillance for DFU pathogens to guide therapy and reduce amputations.

Read full article

Keywords: blaSHV genes, ESBL, diabetic foot ulcers, antibiotic resistance, Uganda DFU

Topical Melatonin Boosts Healing in Diabetic Foot Ulcers

Topical Melatonin Boosts Healing in Diabetic Foot Ulcers

Summary:** A double-blind RCT by Ahmadvash et al. (BMC Endocrine Disorders, 2025) evaluated topical melatonin as adjunct for diabetic foot ulcers (DFUs), showing greater ulcer size reductions and higher healing rates vs placebo, with no significant adverse effects. Melatonin’s antioxidant properties reduce oxidative stress in fibroblasts, enhance enzyme activity, hydrate wound beds, and modulate immunity to prevent infection, positioning it as a safe, affordable add-on to standard debridement/dressings. Limitations include small sample; larger trials needed for dosing/long-term effects.

Key Highlights:

Design: Randomized to melatonin or placebo; primary: % ulcer area reduction; secondary: AEs, pain/comfort.

Outcomes: Melatonin group had greater size reductions and “markedly higher” healing rates; well-tolerated.

Mechanisms: Reduces fibroblast oxidative stress; boosts antioxidant enzymes; hydrates/promotes immune balance.

Implications: Adjunct for DFUs; complements debridement; potential for 50%+ faster closure.

Authors: Ahmadvash F, Gharabagh LH, Emami S et al.

Read full article

Keywords: topical melatonin, diabetic foot ulcer, antioxidant, RCT, oxidative stress

A Comprehensive Review on Diabetic Foot Ulcer Addressing Vascular Insufficiency

A Comprehensive Review on Diabetic Foot Ulcer Addressing Vascular Insufficiency, Impaired Immune Response, and Microbial Dysbiosis

Summary: This narrative review examines the multifactorial pathogenesis of diabetic foot ulcers (DFUs), affecting 15-25% of diabetics and leading to 85% of amputations, driven by vascular insufficiency, peripheral neuropathy, hyperglycemia-induced immune defects, and microbial dysbiosis with biofilms. It discusses diagnostic tools (ABI, TCOM, biopsy) and evidence-based therapies from offloading/compression (TCCs 80% efficacy) to advanced interventions like HBOT (50% closure), growth factors, stem cells, and bioengineered skins (50-70% rates). Microbial shifts (Staphylococcus dominance) exacerbate inflammation; the review advocates personalized, multidisciplinary strategies with AI diagnostics and nanotech antimicrobials to mitigate global burden and enhance limb salvage.

Key Highlights:

Vascular/Neuropathy: Ischemia impairs perfusion; neuropathy masks pain, delaying detection in 60% of cases.

Immune Dysbiosis: Hyperglycemia promotes M1 macrophages; biofilms resist antibiotics in 50% of infected DFUs.

Therapies: Offloading (TCCs 80%); HBOT (50% closure); bioengineered skins (70% in RCTs).

Future: AI for risk prediction; microbiome modulation with phages; nanotech for targeted delivery.

Burden: $15B U.S. cost; 1M global amputations/year; prevention via screening/offloading cuts risk 50%.

Read full article

Keywords: diabetic foot ulcer, vascular insufficiency, immune response, microbial dysbiosis, bioengineered skins, Abdullah Al-Rubaish, Mohammed Al-Rubaish, Ahmad Al-Rubaish

A new injectable hydrogel loaded with exosome modules dramatically accelerates diabetic foot ulcer …

Exosome Modules and Hydrogel Boost Diabetic Foot Healing

Summary: A new injectable hydrogel loaded with exosome modules dramatically accelerates diabetic foot ulcer (DFU) closure in preclinical models. The system promotes angiogenesis, collagen remodeling, and re-epithelialization while reducing inflammation. Researchers report near-complete healing within 14 days versus persistent wounds in controls. The platform’s modular design allows customization of exosome type and dose, paving the way for personalized DFU therapy and potential translation to human trials.

Key Highlights:

Technology: Injectable hydrogel + engineered exosome modules.

Outcomes: ~100% closure in 14 days (vs controls); enhanced angiogenesis & collagen.

Advantages: Modular, tunable, anti-inflammatory, pro-regenerative.

Next Steps: Preclinical → clinical translation for personalized DFU care.

Authors: Not specified (ScienMag summary of peer-reviewed study).

Read full article

Keywords: exosome, hydrogel, diabetic foot ulcer, angiogenesis, personalized medicine, regenerative

Therapeutic Strategies for Managing Diabetic Foot Ulcers and Mitigating Associated Complications

Editorial: Innovative Therapeutic Strategies for Managing Diabetic Foot Ulcers and Mitigating Associated Complications

Summary: Published March 19, 2026 in Frontiers in Pharmacology (Vol. 17, IF 4.8), this editorial by Calvin A. Omolo (United States International University – Africa / University of KwaZulu-Natal), Vinod Kumar Yata (Malla Reddy University, Hyderabad), Yasodha Krishna Janapati, and Sudharshan Reddy Dachani (Shaqra University, Saudi Arabia) synthesizes findings from a 22-article Research Topic on innovative DFU therapeutic strategies and their associated complications. The editorial situates the field within an urgent global context — over 18.6 million new DFUs annually, a lower-extremity amputation every 20 seconds worldwide, and 5-year DFU mortality comparable to many cancers — and argues that conventional care centred on debridement, offloading, and infection control is insufficient for a condition with such devastating consequences. The editorial organises the 22 articles into five thematic pillars. On pharmacological innovation, it highlights a Boruta algorithm-guided approach to antibiotic selection for wound bone cement (Zhang et al.) and the identification of cuproptosis as a novel DFU therapeutic target (Li et al.). On polyherbal formulations, it notes that modern DFU herbal research is increasingly mechanistic, elucidating molecular pathways (NF-κB, Nrf2, growth factor signalling) through which plants like Curcuma longa, Aloe vera, and Centella asiatica promote healing, though standardisation and large RCT evidence remain lacking. On advanced drug delivery systems, the editorial discusses a systematic review and meta-analysis of hyaluronic acid and its derivatives (Yao et al.) and a study showing that NPWT combined with silver-ion dressings reduces IL-6 and TNF-α while improving healing outcomes. On wound microbiome modulation, it covers the contribution of dysbiosis to chronicity and the growing application of algorithm-guided microbiome science to antibiotic therapy. On clinical translation and personalised medicine, it highlights a scoping review of DFU clinical trial design (Zhang et al.) and a validated nomogram predicting moderate-to-severe DFU risk in type 2 diabetes patients (Zhang et al.). The editorial closes with a call for global equity in implementation — addressing the cost-prohibitive nature of advanced biomaterials and complex polyherbal formulations in low- and middle-income countries — and argues for simplified, locally adaptable, task-shifted care models that can deliver innovation equitably.

Key Highlights:

Global DFU burden framing: 18.6 million new ulcers annually, one amputation every 20 seconds worldwide, 5-year mortality rivalling multiple common cancers — yet DFU recurrence and its consequences remain normalised in clinical culture, which the editorial explicitly critiques

Precision pharmacology: algorithm-guided microbiome analysis for antibiotic selection in wound bone cement (moving away from empirical treatment) and cuproptosis as a novel mechanistic DFU target — both requiring substantial further validation before clinical readiness

Polyherbal and natural formulations: key wound-healing herbs (*Curcuma longa*, *Aloe vera*, *Centella asiatica*) showing mechanistic molecular evidence (NF-κB, Nrf2, growth factor signalling), but lacking standardised extracts and large-scale RCTs with hard endpoints such as amputation prevention

Advanced biomaterials: hyaluronic acid derivatives (systematic review confirming moist wound environment maintenance and controlled drug/growth factor release); NPWT + silver-ion dressings (reduced IL-6, TNF-α, and improved healing) — both showing promise but facing cost and regulatory complexity barriers

Clinical translation tools: a scoping review of DFU clinical trial design flaws; a nomogram for individual moderate-to-severe DFU risk prediction in type 2 diabetes patients — both addressing the gap between laboratory innovation and bedside implementation

Global equity imperative: the editorial explicitly calls for parallel development of simplified, affordable, locally sourced adaptations of advanced therapies, including low-cost point-of-care diagnostics, standardised herbal products, and task-shifted care models, to prevent innovation from widening existing health disparities

Read full article

Keywords: diabetic foot ulcer pharmacology, DFU wound microbiome, polyherbal DFU treatment, hyaluronic acid wound healing, precision medicine diabetic foot, DFU global amputation burden

Calvin A. Omolo, Vinod Kumar Yata, Yasodha Krishna Janapati, Sudharshan Reddy Dachani

Lakewood-Amedex Reports Positive Antimicrobial Resistance Data for Lead Candidate Targeting Infected Diabetic Foot Ulcers

Lakewood-Amedex Biotherapeutics Announces Positive Antimicrobial Resistance Data for Lead Candidate Targeting Infected Diabetic Foot Ulcers

Summary: Lakewood-Amedex reported encouraging preclinical data showing minimal resistance development to its novel Bisphosphocin antimicrobial compounds in models relevant to infected diabetic foot ulcers (DFU). With resistant pathogens complicating 15–20% of DFU cases and a massive economic burden, this candidate offers a potential new option with a low propensity for resistance — an important advantage over traditional antibiotics.

Key Highlights:

Low resistance emergence in antimicrobial testing against DFU-relevant pathogens

Addresses critical need in infected DFUs where resistance is common

Supports further development of novel bisphosphocin technology

Read full announcement

Keywords: Bisphosphocin DFU, infected diabetic foot ulcer, antimicrobial resistance wound

METTL16 Identified as Key Regulator in Diabetic Foot Ulcer via m6A Methylation

METTL16 Identified as Key Regulator in Diabetic Foot Ulcer via m6A Methylation

Summary: Using integrated bioinformatics and multiple machine learning algorithms (LASSO, SVM-RFE, GBM), researchers identified 12 differentially expressed m6A-related genes in DFU tissues. METTL16 emerged as the top hub gene, significantly downregulated in diabetic fibroblasts. Knockdown experiments confirmed METTL16 suppression impairs proliferation, migration, and collagen synthesis while promoting apoptosis and inflammation — mirroring DFU pathology. Overexpression partially rescued these defects. METTL16 represents a promising novel therapeutic target for enhancing fibroblast function and accelerating DFU closure.

Key Highlights:

Methods: RNA-seq + WGCNA + LASSO/SVM-RFE/GBM algorithms.

Hub Gene: METTL16 (downregulated in DFU).

Functional Impact: ↓ proliferation/migration/collagen; ↑ apoptosis/inflammation.

Validation: In vitro knockdown/overexpression in diabetic fibroblasts.

Authors: Multiple (bioinformatics + experimental team).

Read full study

Keywords: METTL16, m6A, methylation, diabetic foot ulcer, fibroblast, machine learning

Preventive Care: Reducing the Recurrence of Diabetic Foot Ulcers

Comprehensive treatment of diabetic foot ulcers (DFUs) includes moist local or topical wound care, serial sharp debridement, treatment of infection, mechanical offloading, glycemic control, nutritional management, and overall chronic disease management. These facets of therapy are best addressed by an interdisciplinary approach.

If we understand the principles of healing, what can we do to prevent the pathologic process of DFUs? Instituting measures to prevent development of DFUs can decrease morbidity and mortality. There are several organizations with guidelines for prevention of DFU and subsequent complications including amputation, infection, and loss of independence. This article will review the highlights of some of the most recent guidelines for DFU prevention … read more

Save 2 Feet in 3 Minutes: The Three‑Minute Diabetic Foot Exam

Save 2 Feet in 3 Minutes: The Three‑Minute Diabetic Foot Exam

This educational video, shared by the Southwestern Academic Limb Salvage Alliance (SALSA), introduces the ALPS 3‑Minute Diabetic Foot Exam—an evidence-based, rapid screening protocol designed to identify diabetic foot ulcer (DFU) risk and help prevent lower‑limb amputations in just three minutes.

Key Insights:

Purpose: Provides clinicians with a quick, standardized method to detect neuropathy, vascular compromise, and other DFU risk factors in patients with type 2 diabetes.

Components: Covers monofilament testing for sensation, vibration testing, skin inspection, pulse checks, and footwear assessment.

Efficiency: Designed to fit into a 3‑minute clinical workflow—ideal for primary care and outpatient visits.

Clinical Impact: Promotes early detection and intervention to help reduce the incidence of diabetic foot complications and amputations.

This streamlined foot exam empowers providers to integrate comprehensive risk screening into everyday visits, helping preserve limb health in at‑risk populations.

Keywords:
ALPS,
3‑Minute Foot Exam,
diabetic foot ulcer prevention,
monofilament testing,
vibration testing,
footwear assessment,
limb salvage,
primary care

Watch on YouTube

Efficacy of Cytoreg in the Treatment of Diabetic Foot Disease

Efficacy of Cytoreg in the Treatment of Diabetic Foot Disease

A compassionate-use study evaluated Cytoreg—an investigational aqueous acid blend—administered orally and topically to patients with diabetic foot ulcers (DFUs) over 30 days.

Key Highlights:

Study Design: Ten patients participated. All received oral Cytoreg; five also received weekly topical washes. Wound progress was tracked using the Saint Elian scoring system.

Healing Outcomes: In the oral + topical group, 4 of 5 patients achieved complete healing; the fifth lost necrotic tissue. In the oral-only group, 2 of 4 achieved complete healing.

Systemic Effects: Both groups showed significant rises in arterial hemoglobin and arterial oxygen partial pressure, along with reductions in HbA1c, liver enzymes, creatinine, and urea levels.

Safety & Justification: No major adverse events were noted. Findings support the need for larger, controlled trials.

This preliminary study highlights Cytoreg’s potential to accelerate DFU closure and improve systemic laboratory markers—particularly when combined with topical application. However, randomized controlled trials are needed to validate efficacy and safety.

Based on Carrillo et al., “Efficacy of Cytoreg in the Treatment of Diabetic Foot Disease,” Journal of Wound Care (December 2024).

Keywords: Cytoreg, diabetic foot ulcer, Saint Elian system, acid therapy, systemic oxygen

Read the full article on Wound Central

🔬 Spotlight: Acid-Based Therapies & Oxygen-Enhancing Adjuncts for DFUs

With Cytoreg showing promise as both an oral and topical treatment for diabetic foot ulcers, clinicians may look to similar agents that modulate tissue pH, promote oxygen delivery, or support wound debridement and granulation through biochemical means.

Granudacyn® (Mölnlycke): A hypochlorous-acid–based wound irrigation solution and gel. Offers antimicrobial action while supporting moist wound healing. Safe for long-term use and ideal for DFUs at risk of infection.

UrgoClean Ag® (Urgo Medical): Though not acid-based, this silver-reinforced fiber dressing helps modulate local bioburden and create a favorable wound pH microenvironment for DFU healing.

Topical Oxygen Therapy (e.g., NATROX®, Epiflo®): These devices deliver low-flow oxygen directly to the wound bed, enhancing angiogenesis and collagen synthesis. Similar to the systemic oxygenation improvements seen with Cytoreg in early studies.

pH-modulating gels (e.g., Wound pHarma prototypes): Still investigational, these are designed to shift chronic wound pH from alkaline to mildly acidic, restoring protease activity balance and promoting granulation.

Hydrochlorous Acid Sprays (e.g., Vashe®, Puracyn®): Used for wound cleansing and inflammation control. While not systemic, their acidic pH and antimicrobial profile support wound bed preparation—especially in biofilm-laden DFUs.

Adjuncts that influence the wound’s chemical microenvironment—either through pH, oxygenation, or targeted biochemical pathways—are increasingly seen as critical tools alongside debridement and systemic support in diabetic foot ulcer management. Cytoreg’s dual administration model is an emerging concept worth watching as trials expand.

Diabetic Foot Ulcers and Pressure Injuries: How Do You Tell the Difference?

In evaluating a patient with a wound on the foot, a question that often comes to mind is whether that wound is caused by pressure, diabetes mellitus (DM), ischemia, trauma, or a combination. For example, a patient with DM who happens to have an ulcer on the foot may have a diabetic foot ulcer (DFU) or possibly something else. One of the bigger challenges that many clinicians face is trying to determine the etiology of a foot ulcer. There has been a great deal of debate about DFUs and pressure injuries (PIs) on the feet of patients in terms of how to appropriately assess, classify, and treat them. The confusion and lack of evidence in differentiating between these two types of foot ulcers, particularly on the heel, can lead to misdiagnosis, which can increase both financial and patient-related costs … read more

Diabetic foot ulcer, the effect of resource-poor environments on healing time and direct cost: A cohort study during Syrian crisis

This study was intended to assess the healing time of diabetic foot ulcer (DFU) during what is considered one of the worst humanitarian crises of the 21st century. Researchers examined 1,747 DFUs from the main diabetic foot clinic in Damascus (2014-2019). They conducted SINBAD Classification to grade the severity of ulcers. This study’s findings demonstrate that the environment with resource-poor settings should be added to the traditional risk factors that delay the healing of DFUs for months or even years. There is a need for more studies to analyze low-cost materials that could be cost-effective in applying standard care to the diabetic foot … read more

Study shows how management of serious diabetic foot ulcers was possible during the COVID-19 lockdown

New research being presented at the European Association for the Study of Diabetes (EASD), held online this year (27 Sept-1 Oct), reveals how Belgium’s efforts to maintain a diabetic foot care program during the COVID-19 pandemic can offer valuable lessons to the rest of the world … “Thanks to the great efforts of diabetic foot clinics, continued availability of diabetic foot ulcer services during lockdown, although in a limited capacity, were really helpful, and may be the reason why we didn’t see late presentation and the impact on the severity of ulcers was limited to slightly larger wounds”, says lead author Dr. An-Sofie Vanherwegen from Sciensano … read more

Molecular Biomarkers of Oxygen Therapy in Patients with Diabetic Foot Ulcers

Alisha R. Oropallo 1,*, Thomas E. Serena 2, David G. Armstrong 3 and Mark Q. Niederauer 4
1 Comprehensive Wound Healing Center and Hyperbarics, Department of Vascular Surgery, Zucker School of Medicine Hofstra/Northwell, Hempstead, NY 11549, USA
2 Serena Group Research Foundation, Cambridge, MA 02140, USA; serena@serenagroups.com
3 Limb Preservation Program, Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, CA 90033, USA; armstrong@usa.net
4 EO2 Concepts, San Antonio, TX 78249, USA; m.niederauer@eo2.com
* Correspondence: aoropallo@northwell.edu; Tel.: +1-516-233-3780

Hyperbaric oxygen therapy (HBOT) and topical oxygen therapy (TOT) including continuous diffuse oxygen therapy (CDOT) are often utilized to enhance wound healing in patients with diabetic foot ulcerations. High pressure pure oxygen assists in the oxygenation of hypoxic wounds to increase perfusion. Although oxygen therapy provides wound healing benefits to some patients with diabetic foot ulcers, it is currently performed from clinical examination and imaging. Data suggest that oxygen therapy promotes wound healing via angiogenesis, the creation of new blood vessels. Molecular biomarkers relating to tissue inflammation, repair, and healing have been identified. Predictive biomarkers can be used to identify patients who will most likely benefit from this specialized treatment. In diabetic foot ulcerations, specifically, certain biomarkers have been linked to factors involving angiogenesis and inflammation, two crucial aspects of wound healing. In this review, the mechanism of how oxygen works in wound healing on a physiological basis, such as cell metabolism and growth factor signaling transduction is detailed. Additionally, observable clinical … read more

Diabetic foot ulcer research activity (2004–2020)

The paper I have chosen for this commentary is not a clinical research paper, but hopefully one that will stimulate everyone whether from a clinical, educational, managerial or industry-based workplaces. It is from China, reviewing the global trends for research activity and hotspots in diabetic foot ulceration (DFU). It examined the DFU research activity using the Science Citation Index Expanded (SCI-expanded) of Web of Science Core Collection (WoSCC) using key words, such as ‘diabetic foot ulcer’ or ‘diabetic foot wound’. This database was used as it was deemed to cover most of the high impact and quality international scientific journals. The information of all identified publications included title, year of publication, author, affiliations, nationalities, journal, abstract and keywords. A total of 5,869 publications on DFUs … read more

Distribution and drug sensitivity of pathogenic bacteria in diabetic foot ulcer patients with

necrotizing fasciitis at a diabetic foot center in China

Diabetic foot ulcer is one of the major complications for patients with diabetes, and has become an important cause of non-traumatic amputation. Necrotizing fasciitis is a life-threatening soft-tissue infection involving the fascia and subcutaneous tissue. When diabetic foot ulcers are complicated by necrotizing fasciitis (DNF), this increases the risk for amputation and mortality, making DNF treatment more complicated, and eventually leading to amputation and mortality. However, studies on pathogenic bacteria’s distribution and drug sensitivity in DNF patients remain lacking. This study investigated the distribution and susceptibility of pathogenic bacteria in DNF patients, and provided empirical antibacterial guidance for the clinic … read more

Insulin and Metformin Combo Aids Diabetic Foot Ulcer Healing

Insulin and Metformin Combo Aids Diabetic Foot Ulcer Healing, New Study Finds

A recent study by researchers at Michigan State University and South Shore Hospital has uncovered that combining insulin injections with oral metformin therapy can enhance healing in patients with diabetic foot ulcers (DFUs). The study found that this combination increases the concentration of metformin at the wound site, potentially accelerating the healing process.

Dr. Morteza Mahmoudi, an associate professor at MSU’s College of Human Medicine, noted that their analysis of wound exudates revealed the presence of metformin, suggesting that the combined therapy allows metformin to reach the wound area more effectively. This discovery indicates a synergistic effect between insulin and metformin in promoting wound healing.

Co-researcher Dr. Lisa Gould, a plastic surgeon and wound care clinician at South Shore Hospital and a clinical associate professor at Brown University, emphasized the clinical implications of these findings. The study suggests that clinicians could consider prescribing both insulin and metformin not only for glycemic control but also to enhance local wound healing processes in patients with chronic DFUs.

Read the full article on the Medical Xpress website.

Keywords:
Diabetic foot ulcers,
Insulin therapy,
Metformin,
Wound healing,
Combination therapy,
Michigan State University,
South Shore Hospital

Note: The above synopsis is based on the article’s content and available information. For a comprehensive understanding, please refer to the full article.

Does Cognitive Dysfunction Impact Diabetic Foot Ulcer Outcomes?

Does Cognitive Dysfunction Impact Diabetic Foot Ulcer Outcomes?

In a retrospective study presented at the SAWC Fall Symposium, Dr. Christopher Girgis and colleagues explored how cognitive dysfunction affects healing outcomes in patients with diabetic foot ulcers (DFUs). The findings raise critical considerations for clinicians treating this vulnerable population.

Key Findings:

Patient Profile: The study included 56 patients with DFUs and cognitive dysfunction (mean age 71.9) and 68 patients with DFUs but without cognitive dysfunction (mean age 56).

Healing Outcomes: At 6 months, only 32% of patients with cognitive dysfunction achieved healing, compared to 72% in the non-cognitively impaired group.

Amputations and Admissions: Higher-level amputations were more frequent in the cognitive dysfunction group (17.8% vs 5.9%), and hospital admissions were nearly twice as common (57.1% vs 33.8%).

Clinical Implications: Cognitive dysfunction may severely hinder a patient’s ability to perform self-care, a critical factor in DFU management. Dr. Girgis emphasizes the need for better screening protocols in podiatric settings and urges providers to involve caregivers, initiate referrals to neurology when appropriate, and consider home health or social work support.

Tailored patient education and tighter follow-up protocols may help reduce poor outcomes and guide future prospective studies on cognitive screening tools in wound care.

Keywords:
Christopher Girgis,
Rebecca E. Cohen,
Rostyslav Bublii,
Rimvydas A. Statkus,
diabetic foot ulcers,
cognitive impairment,
amputation risk,
self-care adherence,
SAWC Fall

Read the full article

From Healing to Remission: A Clinician’s Guide to Managing Diabetic Foot Ulcers

From Healing to Remission: A Clinician’s Guide to Managing Diabetic Foot Ulcers

Summary: A new article on Medscape reframes diabetic foot ulcer (DFU) care by encouraging clinicians to view a healed ulcer not as an endpoint, but as a remission state—one that demands ongoing prevention, monitoring, and patient education. The piece outlines proactive strategies to reduce ulcer recurrence, preserve limb function, and sustain long-term patient engagement.

Key Highlights:

Language shift: Using the term “in remission” instead of “healed” helps patients stay aware that DFU is a chronic condition with high risk of recurrence.

Structured limb-preservation plans: Follow-ups every 1-3 months in the first year post-healing, plus risk-based intervals afterward, with regular vascular assessments especially up through 18 months post-closure.

Prevention tools: Thermometry, remote monitoring of temperature/exudate/pressure/moisture, and protective footwear become central components of follow-up care.

Self-management: Patients (or caregivers) should perform daily inspections, recognizing early signs, even in the absence of overt sores; lifestyle moderators like glucose, lipids, and BP control also critical.

Psychosocial support: Screening for depression, social isolation, and other mental health or socio-economic factors that otherwise undermine preventive behaviors and healing maintenance.

Implementation challenges: Shifting to a remission model requires clinic protocol changes, multidisciplinary coordination, and policies that recognize the long-term burden of DFUs and CLTI (chronic limb threatening ischemia).

Read the full article on Medscape

Keywords:
diabetic foot ulcer,
remission model,
limb preservation plan,
thermometry,
patient self-care,
psychosocial support

Knowledge and Practices in Diabetic Foot Ulcer Prevention Among Patients with Diabetes …

Knowledge and Practices in Diabetic Foot Ulcer Prevention Among Patients with Diabetes Mellitus in Gauteng, South Africa

Summary: This research assesses awareness and behaviors related to diabetic foot ulcer prevention among diabetes patients in Gauteng. Findings reveal moderate knowledge but inconsistent daily practices (foot checks, footwear, hygiene), underscoring the need for structured patient education and community programs to reduce DFU incidence and amputations.

Key Highlights:

Knowledge gaps in daily self-care routines

Low adherence to preventive behaviors

Call for culturally tailored education

Read full study

Keywords: DFU prevention, patient education, South Africa diabetes

Digital Health Service for Diabetic Foot Ulcer Risk Stratification

Digital Health Service for Diabetic Foot Ulcer Risk Stratification: Usability Evaluation

Summary: Researchers developed and evaluated a digital health service designed to stratify risk of diabetic foot ulcers (DFU) and support preventive self-care. The platform integrates patient-reported data, education, and risk scoring. Usability testing showed strong user acceptance, ease of use, and potential to strengthen preventive efforts in high-risk diabetes populations, addressing the global need for scalable DFU prevention tools.

Key Highlights:

Digital tool combining risk assessment with patient education and monitoring

High usability scores from both patients and healthcare providers

Supports early identification and timely preventive interventions

Addresses lifetime DFU risk (up to 34%) through accessible technology

Read full open-access article

Keywords: DFU risk stratification, digital health DFU, diabetic foot prevention

The Effect of COVID-19 on Diabetic Foot Ulcer Surgery at a Safety Net Hospital

COVID‑19’s Impact on Diabetic Foot Ulcer Surgeries at a Safety‑Net Hospital

A newly published case series examines how the COVID‑19 pandemic disrupted diabetic foot ulcer (DFU) surgical care at a major safety‑net hospital. The retrospective study evaluated ulcer-related surgeries over a five-year period (March 2018–February 2023), spanning pre-pandemic, pandemic onset, and recovery phases.

Key Findings:

Surgical Volume Trends: Of the 1,858 total DFU-related surgeries reviewed, 723 occurred pre-pandemic, 368 during the initial pandemic year (March 2020–February 2021), and 767 during the two years that followed.

Sharp Decline in Outpatient Access: The onset of COVID‑19 brought immediate restrictions on in-person visits and elective procedures, causing a steep drop in clinic access and early-stage DFU care.

Shift Toward Major Amputations: While minor surgical procedures (e.g., debridement, exostectomy) initially fell, major amputations either remained steady or increased—reflecting more advanced disease upon presentation.

Lasting Disruption: Even two years after reopening, clinic visit volumes remained below pre-COVID levels, underscoring persistent barriers in care continuity for vulnerable patients.

Clinical Implications: Delayed care during the pandemic likely contributed to higher rates of severe complications and limb loss. The authors emphasize the importance of preserving access to wound care services during future healthcare system disruptions.

This study illustrates the critical relationship between timely DFU care and surgical outcomes. The ripple effects of the pandemic continue to inform how healthcare systems should prioritize access and care delivery during public health emergencies.

Keywords:
COVID‑19 and DFU,
safety‑net hospital,
limb salvage,
amputation rates,
healthcare access

Read the full article on HMP Global Learning Network

Use of hypothermically stored amniotic membrane on diabetic foot ulcers

Read full article

Keywords: HSAM, amniotic membrane, diabetic foot ulcers, retrospective case series

Parameters of healing	Group I	Group II
Chronicity of leg ulcer (range)	24–60 months	24–84 months
Chronicity of leg ulcer (mean + SD)	45.82+14.01 months	50.57+16.43 months
Reduction of ulcer size with treatment	0%	100% reduction in size
Reduction of ulcer size with treatment (mean + SD)	0.0+0.0	100.0+0.0
Healing rate cm²/day (range)	0.0–0.0	0.064–2.22
Healing rate cm²/day (mean + SD)	0.0+0.0	0.896±0.646

Ulcer healing	Group I	Group II
No healing	11	100%	0	0%
Complete healing	0	0%	14	100%
Incomplete healing	0	0%	0	0%

Pain level	Group I	Group II
No pain	0	0.0%	3	21.4%
Improved	0	0.0%	11	78.6%
The same	11	100%	0	0.0%

The Neuropathic Diabetic Foot Ulcer Microbiome Is Associated With Clinical Factors

Nonhealing diabetic foot ulcers (DFUs) are a common and costly complication of diabetes. Microbial burden, or “bioburden,” is believed to underlie delayed healing, although little is known of those clinical factors that may influence microbial load, diversity, and/or pathogenicity. We profiled the microbiomes of neuropathic nonischemic DFUs without clinical evidence of infection in 52 individuals using high-throughput sequencing of the bacterial 16S ribosomal RNA gene. Comparatively, wound cultures, the standard diagnostic in the clinic, vastly underrepresent microbial load, microbial diversity, and the presence of potential pathogens. DFU microbiomes were heterogeneous, even in our tightly restricted study population, but partitioned into three clusters distinguished primarily by dominant bacteria and diversity. Ulcer depth was associated with ulcer cluster, positively correlated with abundance of anaerobic bacteria, and negatively correlated with abundance of Staphylococcus. Ulcer duration was positively correlated with bacterial diversity, species richness, and relative abundance of Proteobacteria, but was negatively correlated with relative abundance of Staphylococcus. Finally, poor glycemic control was associated with ulcer cluster, with poorest median glycemic control concentrating to Staphylococcus-rich and Streptococcus-rich ulcer clusters. Analyses of microbial community membership and structure may provide the most useful metrics in prospective studies to delineate problematic bioburden from benign colonization that can then be used to drive clinical treatment … read more

Foot Revascularization Avoids Major Amputation in Persons with Diabetes and Ischaemic Foot Ulcers

The study aims to evaluate the effectiveness of foot revascularization in persons with diabetic foot ulcers (DFUs) and below-the-ankle (BTA) arterial disease. Consecutive patients referred for a new active ischaemic DFU requiring lower limb revascularization were considered. Among those, only patients with a BTA arterial disease were included. Revascularization procedures were retrospectively analysed: in the case of successful foot revascularization (recanalization of pedal artery, or plantar arteries or both) or not, patients were respectively divided in two groups, successful foot perfusion (SFP) and failed foot perfusion (FFP). Healing, minor and major amputation at 12 months of follow-up were evaluated and compared. Eighty patients (80) were included. The mean age was 70.5 ± 10.9 years, 55 (68.7%) were male, 72 (90%) were affected by type 2 diabetes with a mean duration of 22.7 ± 11.3 years. Overall 45 (56.2%) patients healed, 47 (58.7%) had minor amputation and 13 (16.2%) major amputation. Outcomes for SFP and FFP were respectively: healing … read more

Reliability of Microwave Radiometry for the Assessment of Charcot Foot

Comparing Infrared Thermometry and Microwave Radiometry in Monitoring Charcot Foot

A new study published in *Chronic Wound Care Management and Research* evaluates the use of microwave radiometry (MWR) as an alternative to infrared thermometry in diagnosing and monitoring Charcot neuro-osteoarthropathy (CNO) in diabetic patients. The researchers explored how well MWR measurements of internal tissue temperatures agree with standard infrared thermometry, a common method used to detect early inflammatory changes in the diabetic foot.

Key Highlights:

Study Design: The pilot study included 9 individuals with active CNO and 5 diabetic participants without CNO. Temperature was measured using infrared thermometry and MWR sensors of varying diameters (0.8 cm, 2 cm, and 5 cm) to assess different tissue depths.

Measurement Agreement: MWR 0.8 showed strong agreement with infrared thermometry, with an average discrepancy of just 0.034°C (statistically insignificant). However, MWR 2 and MWR 5 showed larger differences (−0.323°C and −0.315°C, respectively), indicating less accuracy for deeper tissue assessment.

Follow-Up Outcomes: Over a median of 67 weeks, 77.8% of participants with CNO had successful offloading with less than a 2°C skin temperature difference. Three participants experienced CNO reactivation weeks after offloading ended, highlighting the importance of precise monitoring during recovery.

Clinical Implication: MWR may serve as a deeper tissue assessment tool, but infrared thermometry remains reliable—especially for surface temperature monitoring in early-stage CNO.

While microwave radiometry shows promise for internal tissue assessment, infrared thermometry remains a practical, cost-effective, and accurate method for tracking Charcot foot inflammation in most clinical settings.

Based on findings published in *Chronic Wound Care Management and Research* (2025).

Keywords:
Charcot foot,
infrared thermometry,
microwave radiometry,
diabetic foot,
offloading

🔬 Spotlight: Tools for Temperature Monitoring in Diabetic Foot Management

Accurate temperature tracking is essential in the early detection and management of Charcot neuro-osteoarthropathy and other diabetic foot complications. Several modern tools now help clinicians and patients monitor inflammation with greater precision and consistency:

Infrared Thermometers: Widely used handheld devices such as the TempTouch® or ThermoFlash® offer quick, non-contact surface readings that help identify at-risk feet before ulceration occurs.

Microwave Radiometry Devices: Though still emerging, MWR systems allow for deeper tissue temperature assessment, potentially identifying inflammation not yet visible at the skin surface.

Smart Insole Systems: Products like Podimetrics SmartMat® or Orpyx SI® continuously track plantar temperature patterns, alerting providers to early warning signs of ulcer formation or reactivation of Charcot foot.

Mobile Integration: Some devices now sync with apps, allowing patients to transmit temperature trends remotely to care teams, supporting proactive intervention and improved adherence.

With technology evolving rapidly, integrating temperature-monitoring tools into diabetic foot protocols can significantly improve early detection, reduce hospitalization risk, and preserve limb function.

read full article

Be ‘Smart’ With New Technology for Diabetic Foot Monitoring

Diabetic foot ulcers are a major health and economic global burden, but ultimately, at least in theory, they’re preventable. The re-ulceration rate is as high as 65% within 5 years, and among persons who initially present with a diabetic foot ulcer, up to 25% may require amputation … One of the most important risk factors for diabetic foot ulceration is diabetic peripheral neuropathy. This involves loss of sensory perception, haptic feedback, and pain perception, so patients can’t self-regulate their foot pressures. It’s thought that these high foot pressures over time cumulatively contribute to the development of diabetic foot ulcers … read more

The Diabetic Foot: Prevention is Paramount

The Diabetic Foot: Prevention is Paramount

Summary: This article emphasizes that prevention remains the most effective strategy for managing the diabetic foot. Highlights key preventive measures: regular risk screening (neuropathy, vascular status), patient education on daily foot inspection and self-care, appropriate offloading and therapeutic footwear, glycemic control, and early multidisciplinary intervention. Discusses the high personal and economic cost of DFUs and amputations, reinforcing that proactive care can dramatically reduce incidence and severity. Calls for heightened awareness among podiatrists and primary care providers to make prevention the default approach in diabetes management.

Key Highlights:

Prevention as the primary goal in diabetic foot care

Screening, education, offloading, and footwear as core strategies

Multidisciplinary approach reduces DFU and amputation risk

Relevance: Foundational message for all diabetic foot programs

Read article

Keywords: diabetic foot prevention, DFU prevention, offloading, patient education

Screening Practices and Risk Stratification for Diabetic Foot Complications in South Africa

Prevalence, Screening Practices and Risk Stratification for Diabetic Foot Complications in Primary Healthcare Clinics: A Cross-Sectional Study in Gauteng Province, South Africa

Summary: This cross-sectional study in Gauteng, South Africa, involved 597 diabetic patients at five primary healthcare centers. Only 10% received diabetic foot assessments, with no risk stratification performed prior. Assessments revealed 30% very low risk, 17% high risk; 19% had active ulcers, 18% in remission; 33% neuropathy, 22% peripheral arterial disease, 17% history of amputation. Risk factors included multimorbidity (p=0.021), poor glycemic control (p=0.003), loss of sensation (p=0.017), and absent pulses (p=0.037). Barriers: inadequate protocols, limited training, high workloads. Implementing routine screening and stratification at PHC could prevent complications, reducing ulcers by up to 50% and amputations by 50-85%.

Key Highlights:

Prevalence: 19% active DFUs; 18% in remission; 33% neuropathy; 22% PAD; 17% amputation history.

Screening: 10% annual; 30% very low risk; 17% high risk; no prior stratification.

Risk: Multimorbidity (p=0.021); poor glycemic control (p=0.003); loss of sensation (p=0.017); absent pulses (p=0.037).

Barriers: Lack of protocols, insufficient training, high workloads (40-50 patients/day), limited resources.

Authors: Ntuli S et al.

Read full study

Keywords: diabetic foot, diabetic foot complications, diabetic foot screening, primary healthcare, risk factors, screening practices, South Africa

Limb salvage surgery in diabetic foot infection: encouraging early results with a local antibiotic carrier

NL Vasukutty, S Mordecai, A Tarik, M Subramaniam, B Srinivasan

Diabetic foot disease is associated with high morbidity and is one of the leading causes of lower limb amputation. The use of a local antibiotic carrier to augment debridement and reconstructive procedures is presented. Methods: The authors present early results of 48 feet in 47 patients from two centres in the UK. Their multidisciplinary protocol involved pre-operative assessment, debridement, culture-specific antibiotics and local antimicrobial management with an antibiotic-loaded biocomposite (CERAMENT G®, BONESUPPORT, Lund, Sweden). Of the 48 feet, 22 (46%) had various foot reconstructive procedures. Six patients had pre-operative revascularisation procedures. All patients were graded as either University of Texas 3B or 3D ulcers. Results: At a mean follow-up of 33 months (range 13–49 months), 42 feet (88%) were free of infection and 39 patients (83%) were mobilising. There were 28 wounds healed by secondary intention, 17 with primary closure and three required skin grafting. Three patients had non-healing and persisting ulcers at the most recent follow-up. Three patients had undergone below–knee amputation. The average time to wound healing was 16 weeks (range 3–24 weeks). A limb salvage rate of 94% was achieved … read more

Staged Limb Salvage in Diabetic Foot Infection

Staged Limb Salvage in Diabetic Foot Infection: A Case Report

Summary: Case: 53M T2DM/pyelonephritis developed necrotizing fasciitis foot. Staged: emergent debridement, electrospun synthetic fiber matrix + NPWT, delayed STSG. Sepsis resolved; >95% graft take; ambulation by 6 weeks post-graft. Demonstrates staged approach with synthetic adjuncts for complex infected DFUs.

Key Highlights:

Progression: Pyelonephritis → necrotizing fasciitis.

Staged: Debridement → matrix/NPWT → STSG.

Outcomes: Full closure, ambulation 6 weeks post-graft.

Authors: Not specified in summary.

Read case

Keywords: staged salvage, necrotizing fasciitis, synthetic matrix, NPWT, DFU

Evaluation of skin perfusion pressure to assess refractory foot ulcers

The number of patients with foot gangrene caused by critical ischaemia and severe infection is increasing significantly in developed countries. The measurement of perilesional skin blood flow by skin perfusion pressure (SPP) is useful to select the appropriate treatment of gangrenous lesions, in that it is not affected by calcifications of blood vessels. However, the prognosis of a foot ulcer may also be affected by the level of blood sugar and infections. This study aimed to validate the use of SPP in cases of foot gangrene and ulcers in patients with and without diabetes mellitus (DM) and infection … read more

Prevention and Management of Diabetic Foot Ulcers

BEST PRACTICE RECOMMENDATIONS FOR THE Prevention and Management of Diabetic Foot Ulcers

Diabetes mellitus (DM) is a metabolic disorder characterized by hyperglycemia that leads to microvascular, macrovascular and neuropathic complications. In 2016, there were 11 million Canadians living with type 1, type 2 or pre-diabetes, and every three minutes another Canadian is diagnosed. Certain populations are at higher risk for developing type 2 DM, including those of Asian, African, Hispanic and Indigenous decent. The rates of DM are three to five times higher in Indigenous populations, an issue compounded by unique barriers to care including, but not limited to, a lack of cultural competency among health-care providers, jurisdictional confusion, limited access to care, geographical location and language barriers.1,2 Foot health should be a major consideration for people with diabetes and for those who care for them. Foot complications in this high-risk population can lead to a cascade of negative complications, potentially resulting in loss of limb and life. The lifetime risk for foot ulceration in people with diabetes is 15 to 25%. According to the International Diabetes Federation … read more (PDF)

Footnotes: Nutritional Considerations For Diabetic Foot Ulcers

Hi, there. My name is Nicole Curreri, and I’m currently a fourth‑year podiatry student at Temple University School of Podiatric Medicine. My co‑authors, Ms. Diana Johnson, who’s a nutritionist and dietician, along with Dr. Khurram Kahn, a DPM at Temple (University School of Podiatric Medicine), have worked together on an article that emphasizes the role of nutrition in healing and treating diabetic foot ulceration.

Podiatrists treat lower extremity wounds secondary to pressure, diabetes, neuropathy, trauma, etc. Most commonly, we treat diabetic foot ulcerations. About 10 to 15 percent of patients with diabetes will go on to develop a diabetic foot ulceration … read more

The patient’s perspective of diabetic foot ulceration

A phenomenological exploration of causes, detection and care seeking
From Rebecca M Crocker, Tze-Woei Tan, Kelly NB Palmer, David G Marrero

Diabetic foot ulceration can contribute to lowered life expectancy and quality of life for people with diabetes, and yet, scant attention has been given to improving preventive and educational measures. This article uses a phenomenological approach to explore individuals’ lived experiences of diabetic foot ulcerations to explore factors that can be harnessed to achieve improved outcomes … This was a qualitative study using semi-structured interviews grounded in a phenomenological framework to explore how patients perceive and understand their foot problems … read more

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Diabetic Foot Ulcers: Offloading, Surgery, and Beyond

Diabetic Foot Ulcers: Offloading, Surgery, and Beyond

Summary: At SAWC Spring 2026, Drs. Paul Kim and Johanna-Marie Richey stressed that successful DFU management requires correcting biomechanical abnormalities rather than focusing solely on wound closure. The session covered comprehensive assessment (perfusion, infection, biomechanics), non-operative offloading strategies, and selective surgical interventions (e.g., flexor tenotomy, metatarsal osteotomy, Achilles lengthening) to reduce recurrence and preserve function.

Key Highlights:

Biomechanical evaluation and weight-bearing imaging are essential

Prioritize adequate offloading before considering surgery

Surgery should target specific mechanical deformities

Goal is durable healing with a functional, stable residual foot

Read full article

Keywords: DFU offloading, diabetic foot surgery, biomechanical DFU

Multiple Interventions for Diabetic Foot Ulcer Treatment (MIDFUT) trial: benefits of involvement for patients and clinicians

Pragmatic diabetic foot ulcer research is key to enhancing clinical expertise and efficiency, patient experience and improved wound healing. Delivery of novel adjuvant therapies in a clinic setting can be challenging, both at clinical and organisational levels. There are many benefits to patients and clinicians from being involved in research. The aim of this article is to present the Multiple Interventions for Diabetic Foot Ulcer Treatment (MIDFUT) trial, describe its purpose, the project implementation and how it is overcoming the challenges of delivering novel therapies in a clinic setting, and the potential benefits to patients and staff … read more

Weekly Debridement Leads to Faster Healing in Diabetic Foot Ulcers

Diabetic foot ulcers debridement should be part of the standard of care, and repetitive weekly debridement may be beneficial … Written by Kristin Della Volpe … Frequent debridement of chronic wounds is associated with improved healing, according to James Wilcox, RN, lead author of a retrospective study of more than 300,000 wounds. Diabetic foot ulcers accounted for a large percentage of these wounds … “An effective healing strategy for chronic wounds should include an early and accurate diagnosis of wound etiology, as well as the appropriate application of debridement and advanced healing modalities in an effort to achieve optimal outcomes,” said Mr. Wilcox, who is Director of Research and Quality for Medical Affairs at Healogics in Jacksonville, FL, and Immediate Past President of the Baromedical Nurses Association … read more

Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers

This paper studies the healing effect of recombinant human epidermal growth factor (EGF) on chronic diabetic foot ulcers. A total of 89 patients (65 male and 24 female) aged from 36 to 82 years (average of 54) enrolled for the prospective, open-label trial, crossover study. Predetermined criteria were used for diagnosis and classification of ulcer. The average duration of ulcer was 6 months (range from 3 to 27 months) prior to study. Upon study, the ulcers were debrided and treated with hydrocolloid or composite dressing depending on the condition of the wound. If treatment effect was minimal using advanced dressing for 3 weeks, patients were crossed over to twice-a-day treatment with 0.005% EGF and advanced dressing. Among the patients, 21 patients showed improvement using hydrocolloid or composite dressing alone and 68 patients were crossed over to treatment with EGF and advanced dressing. In the EGF-treated patients, complete healing was noted in 52 patients within an average of 46 days (range from 2 to 14 weeks). Recurrence was not noted during the 6-month observation. But 5 patients showed new lesions different from the prior site. Sixteen patients required further interventions. This paper suggests that topical treatment with EGF combined with advanced dressing may have positive effects in promoting healing of chronic diabetic foot wounds.

original article from PubMed

Probiotic supplementation aids wound healing in diabetic foot ulcer

Patients with a diabetic foot ulcer who received probiotic supplementation for 12 weeks experienced faster wound healing coupled with an improved glycemic and lipid profile compared with patients assigned placebo, according to findings from a randomized controlled trial.

Sima Mohseni, of the infectious diseases and tropical medicine research center at Babol University of Medical Sciences in Iran, and colleagues analyzed data from 60 adults aged 40 years to 85 years with grade 3 diabetic foot ulcer, who randomly received either probiotic supplementation (n = 30) or placebo (n = 30) daily for 12 weeks between March and June 2016. Probiotic capsules contained lactobacillus acidophilus, lactobacillus casei, lactobacillus fermentum and Bifidobacterium bifidum. All participants also underwent standard treatment for wound care … read more

Assessing Stress During Wound Care

Review: Assessing Stress During Wound Care in Real-Time Using Wearable Sensors

Introduction: The Stress Response in Wound Care in Diabetic Foot Ulcers

Within the last decade, the rise of diabetes in the U.S. population has been matched with a rise in diabetic foot ulcers requiring amputations. Because many of these diabetic foot ulcers develop secondary to poor wound healing and susceptibility to infection after surgery, some important risk factors have been evaluated. Stress, among other factors, has been shown not only to affect the psychological state of a patient, but also biologically to impair immunity and induce an inflammatory microenvironment within patients.

Although previous studies have measured stress by using heart rate and respiration rate during a dressing change lasting three to five minutes, no studies have continuously quantified stress in patients with diabetic foot ulcers during a routine visit. This particular study attempted to examine the stress response in patients with diabetic foot ulcers by using a chest-worn sensor displaying heart rate data. The research team relied on an algorithm to estimate stress that used changes in heart rate variability, a measurement that is taken between two consecutive R waves of an electrocardiogram.

Materials and Methods: Electrocardiographic Monitoring of Wound Dressing Changes in Diabetic Foot Ulcers

Twenty patients with diabetic foot ulcers were recruited from a wound care center and were given the BioHarness3, an FDA approved body device to evaluate single-channel electrocardiogram activity, respiration rate, posture, and core body temperature. To ensure quality control, the team used a smart phone to monitor data in a real-time fashion. This smart phone and BioHarness3 system had a biomodule that was linked to the patient’s body via a biopatch and electrocardiogram electrodes.
read more

Scientists Find Cure For Diabetic Foot Ulcers

Cure For Diabetic Foot Ulcers: People with diabetes, often struggle with diabetic foot ulcers, but not anymore. A team of scientists from the Banaras Hindu University (BHU) have found a cure. The findings of the study were published in the National Centre for Biotechnology Information, National Institutes of Health, US. The team led by Prof Gopal Nath of the department of Microbiology, Institute of Medical Sciences, said that wounds that took months and years to heal, could now be cured in days or months … read more

‘No difference’ between endovascular, open vascular surgeries for diabetic foot ulcers

Adults with diabetic foot ulcers and peripheral artery disease who receive revascularization surgery are at no greater risk for amputation or death following endovascular surgery compared with open vascular surgery, according to findings published in the Journal of Diabetes and its Complications … “The present large cohort study showed in a propensity score-adjusted analysis that there was no difference in amputation-free survival in patients with diabetic foot ulcers and peripheral arterial disease regardless of whether endovascular or open vascular surgery was chosen as first-line vascular intervention,” Talha Butt, MD, of the department of cardiothoracic and vascular surgery at Skåne University Hospital in Sweden … read more

Probiotic supplementation aids wound healing in diabetic foot ulcer

Patients with a diabetic foot ulcer who received probiotic supplementation for 12 weeks experienced faster wound healing coupled with an improved glycemic and lipid profile compared with patients assigned placebo, according to findings from a randomized controlled trial … Sima Mohseni, of the infectious diseases and tropical medicine research center at Babol University of Medical Sciences in Iran, and colleagues analyzed data from 60 adults aged 40 years to 85 years with grade 3 diabetic foot ulcer, who randomly received either probiotic supplementation (n = 30) or placebo (n = 30) daily for 12 weeks … read more

AI x Medicine: Identifying CTSH Gene in Diabetic Foot Ulcer Using Bioinformatics

AI x Medicine: Identifying CTSH Gene in Diabetic Foot Ulcer Using Bioinformatics and Machine Learning

Summary: This Twitter-highlighted publication from the Journal of Inflammation Research (2024) employs bioinformatics and machine learning to pinpoint CTSH as a critical extracellular matrix (ECM)-related gene in diabetic foot ulcers (DFU), validated in mouse models. Analyzing GEO datasets, the study identified CTSH’s upregulation in DFUs, correlating with inflammation and poor healing. ML models predicted CTSH’s diagnostic value (AUC 0.85), while knockdown in mice enhanced wound closure via reduced fibrosis and improved angiogenesis. This positions CTSH as a biomarker/target for personalized DFU therapies, addressing ECM dysregulation in diabetic wounds.

Key Highlights:

Bioinformatics: CTSH upregulated in DFU datasets; enriched in ECM-receptor interaction and PI3K-Akt pathways.

ML Prediction: Random forest model AUC 0.85 for DFU classification; CTSH as top feature.

Mouse Validation: CTSH knockdown accelerated closure (day 14 vs 21), reduced inflammation (IL-6/TNF-α), enhanced collagen deposition.

Clinical Relevance: Potential biomarker for refractory DFUs; therapeutic knockdown to improve healing.

Publication: Journal of Inflammation Research (2024); DOI: 10.2147/JIR.S472345.

Read full article

Keywords: CTSH gene, DFU biomarker, bioinformatics, machine learning, ECM regulation

A Comprehensive Review on Diabetic Foot Ulcer Addressing Vascular Insufficiency ….

A Comprehensive Review on Diabetic Foot Ulcer Addressing Vascular Insufficiency, Impaired Immune Response, and Microbial Dysbiosis

Summary: This narrative review synthesizes DFU’s complex etiology, affecting 15-25% of diabetics and leading to 85% of amputations, driven by vascular insufficiency, neuropathy, hyperglycemia-induced immune defects, and biofilms. It covers diagnostic tools (TCOM, ABI, biopsy) and therapies from offloading/compression to advanced options like growth factors, stem cells, and bioengineered skins (50-70% closure rates). Microbial dysbiosis (e.g., Staphylococcus dominance) exacerbates inflammation; the review calls for personalized, multidisciplinary approaches with AI diagnostics and nanotech antimicrobials to reduce global burden and enhance limb salvage.

Key Highlights:

Vascular/Neuropathy: Ischemia impairs perfusion; neuropathy masks pain, delaying detection.

Immune Dysbiosis: Hyperglycemia shifts macrophages to M1; biofilms (Staph/Pseudomonas) resist antibiotics.

Therapies: Offloading (TCCs 80% efficacy); HBOT (50% closure); bioengineered skins (70% in RCTs).

Future: AI for risk prediction; nanotech for targeted delivery; microbiome modulation.

Burden: $15B U.S. cost; 1M global amputations/year; prevention via screening/offloading.

Read full article

Keywords: diabetic foot ulcer, vascular insufficiency, immune response, microbial dysbiosis, bioengineered skins

Cuba Offers Innovative Treatment for Diabetic Foot Ulcer

Cuba Offers Innovative Treatment for Diabetic Foot Ulcer

Summary: Cuba’s Center for Genetic Engineering and Biotechnology offers Heberprot-P, a recombinant human EGF for DFUs, achieving 75% healing and 70% amputation reduction vs 30% standard. Validated in 100,000+ patients, it’s now available to Ghana for low-cost trials, addressing 15% DFU incidence in diabetics. The therapy promotes granulation and epithelialization, with training for local clinicians to enhance access in Africa.

Key Highlights:

Heberprot-P: EGF stimulates cell proliferation; 75% healing in trials.

Impact: 70% fewer amputations; used in 20+ countries.

Ghana Offer: Low-cost supply; training for MDT implementation.

Global: Addresses 1M annual amputations; affordable for low-resource areas.

Quote: Trivedi: “Innovative solution for DFU crisis in Africa.”

Read full article

Keywords: Heberprot-P, diabetic foot ulcer, EGF, Cuba therapy, amputation reduction

Optimization of Processing Parameters for Autologous Platelet Gel for Diabetic Foot Ulcer

Optimization of Processing Parameters for Autologous Platelet Gel for Diabetic Foot Ulcer

Summary: This study optimizes RAPID Biodynamic Haematogel—a point-of-care autologous platelet gel—for DFU wound healing, identifying centrifugation (1500g, 5 min) for 80% platelet yield and growth factor retention. In 20 DFU patients, gel application post-debridement accelerated granulation 50% vs controls, with 60% closure at 4 weeks. The parameters ensure reproducibility, positioning it as a cost-effective adjunct for chronic ulcers in low-resource clinics.

Key Highlights:

Optimization: 1500g/5 min yields 80% platelets; retains PDGF/VEGF.

Trial: 20 DFU patients; 50% faster granulation; 60% closure at 4 weeks.

Point-of-Care: 30-min preparation; no lab needed.

Safety: No AEs; biocompatible for diabetics.

Authors: Preti M, Barone M, Cavallo S et al.

Read full article

Keywords: autologous platelet gel, diabetic foot ulcer, RAPID Haematogel, centrifugation, growth factors, Preti M, Barone M, Cavallo S

Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial

Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial

Summary: This prospective multicentre RCT (n=218, complex DFUs extending to dermis/bone) compared dehydrated amnion chorion membrane (dACM) + standard of care (SOC) vs SOC alone over 12 weeks. dACM + SOC achieved 50% complete wound closure (CWC) vs 35% for SOC (p=0.04), with median time to CWC 84 days (not achieved for SOC, p=0.04). Hazard ratio 1.48 (95% CI 0.95-2.29) indicated 48% higher closure probability, supporting dACM as effective adjunct for refractory DFUs.

Key Highlights:

Population: 109/group; Wagner grade 2-4; mean duration 4 months, area 3.5 cm².

Outcomes: Week 12 CWC 50% vs 35%; weeks 4/6/8/10: 12%/22%/31%/42% vs 8%/11%/21%/27%.

Method: Cox regression adjusted for duration/area; Kaplan-Meier for time-to-event.

Safety: Similar AEs; dACM applied weekly post-debridement.

Implications: dACM beneficial for deep/chronic DFUs; real-world validation needed.

Read full RCT

Keywords: dehydrated amnion chorion, diabetic foot ulcers, RCT, wound closure, complex DFUs

m6A Regulator METTL16: Breakthrough Target in Diabetic Foot Ulcer Pathogenesis

m6A Regulator METTL16: Breakthrough Target in Diabetic Foot Ulcer Pathogenesis

Summary: Multi-omics (bulk RNA-seq, scRNA-seq, machine learning) across datasets identified 13 DE-MRGs in DFU; METTL16, NSUN3, IGF2BP2 as top biomarkers (AUC 0.93). scRNA-seq showed fibroblast shifts to pro-inflammatory states, with METTL16 dynamic in pseudotime and wound pathways. In high-glucose HSFs, METTL16 overexpression boosted migration/collagen, cut ROS/MDA/apoptosis; knockdown worsened defects. Immune: ↑M1 macrophages, IL-17/MAPK; ↓glutathione metabolism. METTL16 targets epigenetic dysregulation for DFU therapies, enhancing fibroblast repair and reducing inflammation.

Key Highlights:

Biomarkers: METTL16/NSUN3/IGF2BP2 (AUC 0.93 training, 0.85 validation).

Fibroblasts: ↑migration/collagen, ↓ROS/apoptosis with METTL16 OE.

Immune/Pathways: ↑M1/neutrophils, IL-17/MAPK; scRNA: enhanced IGFBP/CD40 signaling.

Validation: qPCR/WB/CCK-8/wound assay in hyperglycemic HSFs.

Authors: Tong Y, Li S, Shen L et al.

Read full study

Keywords: METTL16, m6A, diabetic foot ulcer, fibroblast, multi-omics, epigenetic

Facility-Level Variation in Major Leg Amputation Among Veterans With Newly Diagnosed Diabetic Foot Ulcers

Facility-Level Variation in Major Leg Amputation Among Veterans With Newly Diagnosed Diabetic Foot Ulcers

Summary: This large retrospective cohort study analyzed 86,094 Veterans (mean age 73) newly diagnosed with diabetic foot ulcers across 140 VA facilities from 2016–2021. Within one year, 3.8% underwent major leg amputation. After adjusting for patient comorbidities and social drivers of health, there was significant facility-level variation: the median odds ratio (MOR) for major amputation was 1.85 — meaning the odds were 1.85 times higher at one random facility compared to another for an otherwise similar patient. Facility variation in 1-year mortality was much smaller (MOR 1.16). The findings suggest that differences in DFU-specific care (offloading, vascular evaluation, multidisciplinary management, timely intervention) are major drivers of amputation risk and represent important targets for quality improvement.

Key Highlights:

3.8% major amputation rate within 1 year of new DFU diagnosis

Facility-level median odds ratio of 1.85 for amputation (wide range 0.29–3.53)

Variation in amputation far exceeded variation in mortality, pointing to modifiable care differences

Authors: Hiroyuki Suzuki, MD, MSCI, et al. (JAMA Network Open, 2025)

Read full article (JAMA Network Open)

Keywords: VA DFU amputation, facility variation amputation, Hiroyuki Suzuki

C-Reactive Protein-to-Albumin Ratio Improves Prediction of 6-Month Major Adverse Limb Events in Patients with Diabetic Foot Ulcers

C-Reactive Protein-to-Albumin Ratio Improves Prediction of 6-Month Major Adverse Limb Events in Patients with Diabetic Foot Ulcers

Summary: This retrospective study evaluated the prognostic value of the C-reactive protein-to-albumin ratio (CAR) in patients with diabetic foot ulcers (DFU). CAR, a readily available inflammatory biomarker, demonstrated strong independent predictive power for 6-month major adverse limb events (MALE), including major amputation and revascularization. Adding CAR to traditional risk models significantly improved discrimination and reclassification. The authors conclude that CAR is a simple, inexpensive tool that can help clinicians better stratify risk and guide intensified interventions in high-risk DFU patients.

Key Highlights:

CAR independently predicts 6-month MALE in DFU patients

Improves model performance when added to conventional risk factors

Low-cost, routinely available biomarker from standard labs

Useful for early risk stratification and personalized care

Read full open-access article

Keywords: CRP albumin ratio, DFU prognosis, major adverse limb events

C-Reactive Protein-to-Albumin Ratio Improves Prediction of 6-Month Major Adverse Limb Events in Patients with Diabetic Foot Ulcers

C-Reactive Protein-to-Albumin Ratio Improves Prediction of 6-Month Major Adverse Limb Events in Patients with Diabetic Foot Ulcers

Summary: This retrospective study evaluated the prognostic utility of the C-reactive protein-to-albumin ratio (CAR) in patients with diabetic foot ulcers (DFU). CAR, a simple and inexpensive inflammatory biomarker calculated from routine labs, emerged as a strong independent predictor of 6-month major adverse limb events (MALE), including major amputation and revascularization. Incorporating CAR into existing risk models significantly improved discrimination and net reclassification. The authors propose CAR as a practical tool for early identification of high-risk DFU patients who may benefit from more aggressive multidisciplinary intervention.

Key Highlights:

CAR independently predicts 6-month MALE in DFU patients

Improves predictive performance of traditional risk models

Low-cost biomarker readily available from standard bloodwork

Potential for better risk stratification and timely limb-preservation strategies

Read full open-access article

Keywords: CRP albumin ratio DFU, major adverse limb events, DFU prognosis

Use of Three-Dimensional Acellular Collagen Matrix in Deep or Tunnelling Diabetic Foot Ulcers

Use of Three-Dimensional Acellular Collagen Matrix in Deep or Tunnelling Diabetic Foot Ulcers: A Retrospective Case Series

Summary: This retrospective case series evaluated the application of a three-dimensional acellular collagen matrix in patients with deep or tunnelling diabetic foot ulcers. The matrix provided excellent scaffold support, promoting robust granulation tissue formation even in challenging cavity wounds. Most patients achieved complete healing with reduced need for more invasive interventions, highlighting its utility as an adjunct in complex DFU management.

Key Highlights:

Effective for deep, tunnelling, and undermined DFUs

Rapid granulation and wound filling observed

Well-tolerated with good integration

Potential to simplify management of cavity wounds

Read full article

Keywords: 3D acellular collagen matrix, tunnelling DFU, cavity wound healing

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers

Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers: A Multicentre Retrospective Case Series

Summary: This multicentre retrospective study assessed hypothermically stored amniotic membrane (HSAM) in real-world treatment of diabetic foot ulcers. The advanced tissue product supported consistent healing across multiple centres, demonstrating good integration, reduced healing time, and low complication rates. Results reinforce HSAM as a reliable option for hard-to-heal DFUs.

Key Highlights:

Strong healing outcomes in a multicentre real-world setting

Effective for chronic, non-healing DFUs

Favourable safety and integration profile

Practical adjunct for advanced wound care teams

Read full article

Keywords: hypothermically stored amniotic membrane, HSAM DFU, amniotic membrane wound

Carbopol® 940 Hydrogel Functionalised with Plasma-Activated Water: An Advanced Platform for Diabetic Foot Ulcer Management

Carbopol® 940 Hydrogel Functionalised with Plasma-Activated Water: An Advanced Platform for Diabetic Foot Ulcer Management

Summary: This study evaluated a Carbopol 940 hydrogel enriched with plasma-activated water (PAW). In a clinical case of a recalcitrant Wagner Grade 2 diabetic foot ulcer, the hydrogel applied as monotherapy (without systemic antibiotics) achieved complete healing. The platform combines antimicrobial properties with a supportive moist environment, showing strong potential for advanced wound care.

Key Highlights:

Successful monotherapy healing of hard-to-heal Wagner Grade 2 DFU

Strong antimicrobial and pro-regenerative effects from PAW

Promising advanced hydrogel platform for infected/chronic wounds

Potential to reduce reliance on systemic antibiotics

Read full open-access article

Keywords: plasma activated water DFU, Carbopol hydrogel, advanced DFU hydrogel

Beating Biofilm Is Key to Fighting Surgical Infections

Health care is at a perilous crossroads. “[D]eaths from drug-resistant infections are set to skyrocket to over 10 million per year worldwide and could cost the global economy as much as $100 trillion by 2050,” a STATISTICA article reports. The same concerning fact is stressed by United States public health officials, who agree that “antimicrobial resistant pathogens (AMR) threaten everyone”.Both reports suggest a grim future of consequences from bacterial resistance, with U.S. officials believing AMR is occurring at a rate of more than 2.8 million antibiotic resistant infections in the U.S. each year, ending in a heavy economic price and over 35,000 deaths annually. The Centers for Disease Control and Prevention (CDC) believes “no one can completely avoid the risk of resistant infections, with some people at greater risk than others.” Eye-opening research suggests at least 80% of these infections are biofilm related … read more

Topical Nystatin Treatment for Candida Infection

Abstract

Introduction. Wound infection is an important cause of nonhealing wounds and graft rejection. Objective. A series of 5 patients (4 females, 1 male; median age, 50; age range, 1.5–83 years) with nosocomial Candida infection of burns and chronic wounds that were reconstructed with split-thickness skin grafts is presented.

Materials and Methods. This case series was carried out between February 2011 and June 2014. Based on tissue cultures, wounds were treated with 100 000 units/mL of nystatin and 25 mg in 500 cc normal saline of mafenide acetate, which resulted in regression of wound infection symptoms and improvement of skin graft take. Conclusions. The authors propose this simple, nontoxic, and economic topical treatment for wounds and skin grafts with positive Candida cultures.

Infection is a common local factor that impedes wound healing. Hence, a topical antimicrobial dressing is frequently used to control bacterial proliferation.1 Since the introduction of effective topical antibacterial therapy, fungal infections have become more prevalent, especially in burn patients … read more

Effective Wound Dressing Securement for Infection Prevention

In order to promote rapid healing, improve patient comfort and prevent complications, it is important that healthcare professionals actively work to prevent infection. One key component of that effort is wound dressing securement. Secure, gentle and effective dressings can help prevent the ingress of foreign material, reduce damage during dressing changes and help foster an ideal healing environment. This can help reduce the risk of infection, improving patient outcomes and lowering costs.1 In this post, we will explore the importance of infection prevention and effective dressing securement strategies to help prevent infection … read more

Wound Infection in Clinical practice – principles of best practice

We have over 100 resources, free for everyone to browse and read and share. These resources are suitable for a range of skin and wound care disciplines, roles, and educational purposes
Wound infection continues to be challenging for people with a wound, their families and health professionals. Wound infection can lead to protracted wound healing, multiple health service visits and increased hospital admission duration. This comes at significant economic cost and negatively impacts quality of life outcomes for the person with a wound and their family. Accurate and timely identification of the signs and symptoms of wound infection are critical to achieving effective management of wound infection … read more

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neoplas med GmbH: Superiority of cold atmospheric plasmajet therapy in the treatment of

chronic wounds proven by gold-standard trial

Comparative clinical trial shows significant improvement in wound closure and infection control based on treatment with the plasmajet kINPen® MED from neoplas med compared to best practice wound care – cost-effectiveness analysis proves high cost-savings by innovative technology

GREIFSWALD, Germany and FELDKIRCH, Austria, March 22, 2022 /PRNewswire/ — The results of a randomized controlled trial (RTC) may offer new opportunities for the approximately two million patients with chronic wounds solely in Germany: The innovative cold atmospheric plasmajet (CAP-jet) technology showed significantly more healing progress in chronic wounds in comparison to best practice (BP) modern wound care at two study centers. Within six weeks, 59 percent of all wounds healed completely under cold plasma treatment compared to only 5.1 percent in patients under BP therapy. Time to complete healing was also considerably shorter under CAP-jet treatment, and wound infections were overcome statistically significant more rapid. With a very good tolerability profile, an economic analysis of the study data also showed a cost saving of 65 percent for the dressing material alone compared to the BP group. The study data were recently published in the journal Nature Scientific Reports.

Acceleration of wound healing and wound closure proven

In the study conducted by Prim. Univ.-Professor Robert Strohal, head of the Department of Dermatology and Venereology at the Federal Academic Teaching Hospital Feldkirch, the cold plasma procedure of the Greifswald-based company neoplas med GmbH was scientifically examined in wound care. For this purpose, he compared treatment with the CAP-jet kINPen® MED at the Austrian Federal Academic Teaching Hospitals Feldkirch and Bregenz with current best practice treatment in 78 patients with infected and non-infected wounds. ‘This study was the first to investigate the exclusive effect of tissue accessible cold plasma on wound healing and infection control without the use of an additional standard therapy,’ said Prim. Univ.-Prof. Strohal.

After treatment with the CAP-jet, the proportion of healthy tissue increased significantly faster than under the BP treatment and the wounds under CAP-jet therapy also healed significantly faster. At the end of the study, the wound area in the CAP group had reduced by 94.7 percent compared to the baseline value, in the comparison group it was only 56.3 percent. CAP also proved superior in terms of infection control. In contrast to BP therapy, all wounds infected at the start of the study showed complete resolution of infection signs. In addition, the signs of infection disappeared significantly faster under cold plasmajet therapy.

Patients’ quality of life can improve

Ulrike Sailer, CEO of the company neoplas med GmbH in Greifswald/Germany, explained: ‘The Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA) as the central decision-making body of the German health care system already recognized last year the potential of cold plasma for the innovative treatment of chronic wounds at our request. Therefore, the G-BA decided to carry out an observational trial for testing with the aim of obtaining health insurance approval. The results of the clinical trial that now have been published clearly demonstrate the superiority of the CAP-jet kINPen® MED compared to BP wound care. These results provide further evidence for the high clinical relevance of the CAP-jet precision technology. At the same time, it represents important news for millions of people who suffer from chronic wounds for years.’

Chronic wounds are often associated with high morbidity and considerable impairments in everyday life as well as the patients’ psyche. Faster wound healing and thus a shorter therapy duration by using the plasmajet kINPen® MED can therefore significantly improve the patients’ quality of life. Furthermore, a lower burden by pain during treatment can be observed, and a reduced number of dressing changes can be assumed. Patients confirmed the very good tolerability and even described the treatment as pleasant in the majority of cases.

Significant advantage in treatment costs

A cost-effectiveness analysis based on the available study data showed that 21.4 percent fewer physician visits and 34.3 percent fewer dressing changes were necessary in the CAP-jet group compared to BP. The savings alone in dressing material resulted in a cost advantage for CAP-jet therapy of 64.7 percent compared to BP. Previously, average costs of 10,000 € per patient and year were assumed. Ulrike Sailer: ‘Thus, the cold plasmajet kINPen® MED offers not only a more efficient and tolerable technology, but also opens up the opportunity for significantly higher cost-effectiveness in the treatment of chronic wounds.’

Further information material can be found under the following link: https://1drv.ms/u/s!Aph6cOwNbPEJgQCIbClSETCZ_lal?e=BvkuGi

Background Information:

The study included 78 patients with wounds up to 10 x 20 cm in size and existing for at least 6 weeks. The patients were randomized in a 1:1 ratio into two groups and treated for the study duration of 6 weeks either with the CAP-jet kINPen® MED (30 seconds per cm2 wound area) or suitable wound dressings according to BP wound care. Only one wound per patient was evaluated.

With regard to the treatment regime, CAP-jet therapy was administered 3 times in the 1st week in the CAP group, 2 times in the 2nd week and once a week in the following observation period; furthermore, the wounds were covered with gauze and a secondary dressing. In contrast, the BP group was treated with a wound phase-adapted dressing; infected wounds were additionally cleaned with an antiseptic. In both groups, patients with venous ulcers received compression therapy. The primary endpoint of the study was the amount of granulation tissue at the end of the study. In addition, cold plasma effects on wound infection, wound area, healing time, wound pH and exudate volume (wound fluid) as well as local tolerability were investigated.

Improvement in wound infection: All 13 wounds infected at baseline in the CAP-jet group showed complete resolution of infection signs without the need for additional antiseptics. In contrast, 4 of the 18 wounds infected at baseline in the BP group showed no improvement despite the use of antiseptics. Furthermore, the signs of infection decreased significantly faster under CAP-jet therapy compared to BP therapy. These data confirm the previously published evidence on the good antimicrobial efficacy of CAP.

Cold plasma is a gas containing ionized atoms, ions and electrons that has been shown to disinfect wounds and activate the wound healing process. With its fine jet, the plasmajet kINPen® MED enables highly precise treatment in anatomically and pathologically challenging areas under visual control and without touching, which is not possible with other wound therapies.

About neoplas med GmbH

neoplas med GmbH was founded in 2009 as a spin-off of the Leibniz Institute for Plasma Science and Technology e. V. (INP) in Greifswald, Germany. Ulrike Sailer took over the position of managing director at the end of 2019. Based on the INP research into plasma medicine, the emerging company develops innovative products for medical applications. The first product developed on this basis is the CE-marked kINPen® MED atmospheric pressure plasmajet, the first internationally approved and marketed plasmajet for the treatment of chronic wounds and pathogen-induced skin disorders. It is the result of a long-lasting cooperation with the INP institute, the university hospital of Greifswald, Germany, the Charité hospital of Berlin, Germany, and various industrial partners. In July 2021, the Federal Joint Committee, as the central decision-making body in the self-governing health care system, decided on a trial study with the cold plasmajet procedure and thus took an important step towards reimbursement by the health insurance companies.

About kINPen® MED

The plasmajet kINPen® MED is the first atmospheric pressure plasmajet to receive CE approval for the treatment of chronic wounds and pathogen-induced skin disorders. The plasmajet applies a physical cold plasma with a temperature of < 40 degrees Celsius with pinpoint precision and without wound contact. Areas with an uneven profile, recesses or cavities can be reached easily and treated evenly. The noble gas argon used for the generation of the plasma provides a controlled atmosphere around the generated plasma beam, thus ensuring a consistent high treatment quality.

Press contact

Claudia Kerber
Phone: +49 3834 515 201
Mobile: +49 (0)162 23 770 70
claudia.kerber@neoplas-med.eu
neoplas med GmbH
Walther-Rathenau-Straße 49a, 17489 Greifswald, Germany

Army R&D selects local biotech firm to prevent wound infection

Press release from MLM Biologics Inc.

GAINESVILLE, Fla. – The U.S. Army Medical Research and Development Command (USAMRDC) recently awarded MLM Biologics, Inc. almost $1.5 million to develop a device to prevent infection in battlefield wounds. The device will incorporate MLM Biologic’s proprietary collagen processing and stabilization technologies.

MLM Biologics competed for the award in the battlefield treatment area, focused on preventing infection in wounds from “…complex, traumatic, penetrating injuries in a far-forward, austere environment.”

“We’re honored to bring our innovative solutions to the men and women who stand in harm’s way as our focus has always been on wound closure—not just wound management,” says CEO Chandra Nataraj.

As part of the award, MLM Biologics will develop a new medical device using its proprietary technologies combined with proven anti-inflammatory and anti-microbial components, Nataraj said. He believes it will eventually be available for civilian clinical use.

“We expect to make a difference, not only for our military heroes but eventually for everyone dealing with possible wound infection. The potential health benefits are huge,” Nataraj says.

The company maintains labs at the University of Florida’s business incubator, UF Innovate | Accelerate @ Sid Martin Biotech, where it conducts product development activities. Karl R. LaPan, UF Innovate | Accelerate director, believes MLM Biologics represents the tangible benefits incubators provide.

“MLM Biologics, and the development of a treatment to prevent wound infection, is a great example of public-private partnerships translating research into meaningful, life-changing products for America’s service members,” LaPan said.

The award is part of the Military Prototype Advancement Initiative, funded by the Department of Defense and issued through the Medical Technology Enterprise Consortium, a collaboration of industry and academia to facilitate R&D activities with USAMRDC and other government agencies.

About MLM Biologics, Inc.

MLM Biologics is a privately held medical device company specializing in the design, manufacture, and marketing of biologic medical devices. The company was founded on the modern interpretation of the Gandhian economic principle of “More for Less for Many.” It currently distributes an FDA-cleared wound care device (bio-ConneKt® Wound Matrix) out of its ISO-13485-certified facility in Gainesville, Fla. For more information, visit www.MLMBiologics.com.

Posted in Articles

Largest Published Real-World Wound Imaging Study Reports MolecuLight®

by admin on May 23, 2023

…treatment plan changes using MolecuLight imaging for a stalled diabetic foot ulcer (DFU) exhibiting delayed healing but no signs or symptoms of infection. Standard (ST) and fluorescence (FL) images (MolecuLight)…

Health Care Costs and Clinical Outcomes of Necrotizing Soft Tissue Infections

Skin-Sparing Surgery Reduces Costs and Improves Outcomes in Necrotizing Soft Tissue Infections

A recent study published in Wounds evaluates the effectiveness of skin-sparing surgery (SSS) in managing necrotizing soft tissue infections (NSTIs). Conducted at a regional burn and wound center, the research highlights how SSS can lead to better clinical outcomes and lower healthcare costs for patients suffering from these severe infections. :contentReference[oaicite:2]{index=2}

Key Highlights:

Improved Clinical Outcomes: Patients undergoing SSS experienced reduced mortality rates and shorter hospital stays compared to traditional surgical approaches.

Cost-Effective Treatment: The SSS approach was associated with decreased healthcare costs, making it a financially viable option for managing NSTIs.

Preservation of Healthy Tissue: SSS focuses on removing necrotic tissue while preserving viable skin, facilitating better wound healing and potentially reducing the need for complex reconstructive procedures.

This study underscores the potential of skin-sparing surgery as a beneficial strategy in the treatment of necrotizing soft tissue infections, offering both clinical and economic advantages.

Read the full article on the Wounds website.

Keywords:
necrotizing soft tissue infection,
skin-sparing surgery,
wound care costs

Mayo Clinic Researchers Develop AI Tool to Detect Surgical Site Infections From Patient-Submitted Photos

Mayo Clinic Researchers Develop AI Tool to Detect Surgical Site Infections From Patient-Submitted Photos

Summary: Researchers at Mayo Clinic have developed an artificial intelligence (AI) system that analyzes patient-submitted wound photos to detect surgical site infections (SSIs) with high accuracy. The tool uses a two-stage pipeline to first identify incisions in the image, then flag signs of infection. It was trained on a dataset of over 20,000 images from more than 6,000 patients across nine Mayo hospitals. The AI achieved ~94% accuracy in incision detection and 0.81 area under the curve (AUC) for SSI detection. (Mayo Clinic News Network) :contentReference[oaicite:0]{index=0}

Key Highlights:

Two-stage model: The pipeline first confirms presence of a surgical incision, then assesses infection risk within the incision area.

Model performance: Incision detection accuracy ~94%; SSI detection AUC ~0.81 across validation sets. :contentReference[oaicite:1]{index=1}

Diverse dataset: Trained across multiple centers, the system demonstrated consistent performance across racial groups, helping mitigate bias concerns. :contentReference[oaicite:2]{index=2}

Clinical value: Automating image triage may reduce clinician workload, accelerate post-operative surveillance, and prompt timely intervention. :contentReference[oaicite:3]{index=3}

Next steps: Prospective validation and integration into care workflows are underway. :contentReference[oaicite:4]{index=4}

Read the original article on Arab News

Keywords:
Hala Muaddi,
Cornelius Thiels,
Hojjat Salehinejad,
AI for SSIs,
postoperative monitoring,
wound imaging

Effect of Negative Pressure Wound Therapy on Abdominal Deep Incisional Surgical Site Infections

Effect of Negative Pressure Wound Therapy on Abdominal Deep Incisional Surgical Site Infections

Summary: This original research evaluates negative pressure wound therapy (NPWT) versus standard dressings for preventing and managing deep incisional surgical site infections (SSIs) after abdominal surgery. NPWT significantly reduced infection rates, accelerated granulation, and shortened healing time. Patients treated with NPWT required fewer reoperations and had lower overall complication rates. The therapy helps manage exudate, reduce edema, and improve tissue perfusion in high-risk incisions. Supports NPWT as an effective prophylactic and therapeutic tool in abdominal wound care, particularly in patients with comorbidities (diabetes, obesity) that increase SSI risk.

Key Highlights:

Reduced incidence and severity of deep incisional SSIs

Faster healing and fewer reoperations with NPWT

Benefits in high-risk abdominal surgery patients

Relevance: Evidence for NPWT in surgical wound complications

Read full research

Keywords: NPWT, surgical site infection, abdominal wound, incisional SSI

Bacteria Suppress Immune Defenses in Wound Infections

Bacteria Suppress Immune Defenses in Wound Infections

Summary: Recent research has uncovered mechanisms by which pathogenic bacteria suppress the host immune response during wound infections. The study shows that specific bacterial strategies can dampen immune cell activity, allowing persistent infection and delayed healing in chronic wounds. These findings deepen understanding of host-pathogen interactions and open new avenues for developing targeted therapies that counteract bacterial immune evasion. By addressing these suppression tactics, future wound care approaches could restore effective immune function and accelerate healing in difficult-to-treat infected wounds.

Key Highlights:

Bacteria employ active strategies to suppress immune defenses

Mechanism contributes to chronicity and poor healing in wounds

Offers new targets for anti-infective and immunomodulatory therapies

Relevance: Advances understanding of infected chronic wounds

Read full article

Keywords: bacterial immune suppression, wound infection, chronic wound healing

A Preliminary Exploration of the Efficacy of Gentamicin Sponges in the Prevention and Treatment of Wound Infections

Gentamicin sponges, implantable topical antibiotic agents, are approved for surgical implantation in 54 countries. Since 1985, more than one million patients have been treated with these sponges.1–3 However, despite having been studied for over 30 years, their effectiveness is still disputed … Han et al have found that applying gentamicin-impregnated sponges during spinal operations significantly decreases surgical-site infection (SSI).4 Chang et al have conducted a meta-analysis encompassing 15 randomized control trials and also concluded that gentamicin sponges decrease the rate of SSI.5 Schimmer et al have used a controlled, prospective, randomized double-blind study to investigate the efficacy of gentamicin sponges in sternal wound complications after heart surgery. They enrolled 720 patients and found that gentamicin sponges effectively reduce infection complications … However, several other studies have demonstrated that gentamicin-impregnated sponges cannot reduce SSI, and some researchers have even proposed that the sponges increase the risk of infection. Wouthuyzen-Bakker et al have discussed the efficacy of applying gentamicin-impregnated sponges locally during debridement in early acute periprosthetic joint infections. They found that their application does not reduce the incidence … read more

Artacent Amniotic Tissue for Chronic Lower Extremity Diabetic Ulcers

Clinical Trial: Artacent Amniotic Tissue for Chronic Lower Extremity Diabetic Ulcers

Summary: Sponsored by Tides Medical, this completed interventional Phase 2 trial (NCT07219004, started March 3, 2023) investigates the efficacy of Artacent—a tri-layered dehydrated human amnion/chorion/amnion composite graft—as a treatment for chronic lower extremity diabetic ulcers persisting despite standard care. Enrolling patients with non-healing wounds, the study assesses whether the amniotic tissue promotes closure over 12 weeks, addressing the high burden of diabetic ulcers that affect millions and often lead to amputations. While specific outcomes remain pending publication, the trial underscores amniotic products’ potential in regenerative wound healing by providing a structural matrix for tissue repair and reducing inflammation.

Key Highlights:

Trial design: Interventional, single-group assignment; focuses on 12-week healing in chronic diabetic lower extremity ulcers.

Product: Artacent tri-layered graft supports cellular migration and vascularization for stalled wounds.

Relevance: Targets non-healing ulcers post-standard care, common in diabetics with vascular/neurological complications.

Sponsor: Tides Medical; status: Completed (recruitment finished); no interim efficacy/safety data released yet.

Implications: Builds evidence for amniotic membranes in DFU management, potentially improving closure rates and limb salvage.

Read full article

Keywords: Artacent, amniotic tissue, diabetic ulcers, phase 2 trial, regenerative graft

Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers

Clinical Trial: Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers

Summary: Sponsored by Tides Medical, this completed interventional Phase 2 trial (NCT07219004, started March 3, 2023) investigates the efficacy of Artacent—a tri-layered dehydrated human amnion/chorion/amnion composite graft—as a treatment for chronic lower extremity diabetic ulcers persisting despite standard care. Enrolling patients with non-healing wounds, the study assesses whether the amniotic tissue promotes closure over 12 weeks, addressing the high burden of diabetic ulcers that affect millions and often lead to amputations. While specific outcomes remain pending publication, the trial underscores amniotic products’ potential in regenerative wound healing by providing a structural matrix for tissue repair and reducing inflammation.

Key Highlights:

Trial design: Interventional, single-group assignment; focuses on 12-week healing in chronic diabetic lower extremity ulcers.

Product: Artacent tri-layered graft supports cellular migration and vascularization for stalled wounds.

Relevance: Targets non-healing ulcers post-standard care, common in diabetics with vascular/neurological complications.

Sponsor: Tides Medical; status: Completed (recruitment finished); no interim efficacy/safety data released yet.

Implications: Builds evidence for amniotic membranes in DFU management, potentially improving closure rates and limb salvage.

Read full article

Keywords: Artacent, amniotic tissue, diabetic ulcers, phase 2 trial, regenerative graft

Key risk factors for diabetic foot reinfections uncovered in study

by Claire Kowalick, University of Texas Health Science Center at San Antonio

Texas has one of the highest rates of diabetes in the country, with more than 2.7 million Texans diagnosed with the condition. About one in six people in San Antonio have type 2 diabetes, and a third of residents are prediabetic, according to the American Diabetes Association.

Type 2 diabetes is a chronic condition in which the body cannot produce enough insulin or use insulin properly and, if left uncontrolled, can lead to high blood sugar, heart disease and kidney failure. It also predisposes people to foot ulcers, of which almost 50% become infected, subsequently leading to hospitalization and potentially amputation of part of the foot or a lower limb … full article

related:

Texas has one of the highest rates of diabetes in the country, with more than 2.7 million Texans diagnosed with the condition. This epidemic has significant implications for healthcare systems, particularly in the management of complications like diabetic foot ulcers (DFUs). In San Antonio, where approximately one in six residents has type 2 diabetes and a third of the population is prediabetic, the risk of developing DFUs is alarmingly high.

Diabetic foot ulcers result from a combination of neuropathy, poor circulation, and impaired immune response, all of which are common in individuals with long-standing diabetes. Without proper intervention, these ulcers can progress to severe infections, leading to hospitalizations, amputations, and increased mortality rates. Given the high prevalence of diabetes in Texas, hospitals and wound care centers face mounting challenges in treating and preventing these wounds effectively.

The economic burden of DFUs is also substantial. Studies indicate that treating a single DFU can cost tens of thousands of dollars, with the total cost of diabetic foot care in the U.S. exceeding billions annually. In areas like San Antonio, where diabetes rates are disproportionately high, local healthcare facilities must prioritize specialized wound care services, early detection, and preventive measures such as total contact casting (TCC) to offload pressure from wounds and enhance healing.

Community-wide initiatives are essential to combat this growing crisis. Increasing awareness about proper foot care, expanding access to podiatric and wound care specialists, and implementing preventive strategies—such as routine screenings for neuropathy and peripheral artery disease (PAD)—can significantly reduce the incidence and severity of DFUs. Additionally, addressing social determinants of health, such as limited access to quality healthcare, lower socioeconomic status, and dietary challenges, is crucial in mitigating the long-term consequences of diabetes-related foot complications.

As Texas continues to grapple with rising diabetes rates, proactive intervention and innovative wound care solutions will be key in preventing DFUs and improving patient outcomes.

Corstrata Foot Ulcer Prevention Solution

Named Among Semifinalists For T1D Exchange 2018 Diabetes Innovation Challenge

Corstrata provides new tech empowered diabetic foot ulcer prevention to improve patient lives.

CORSTRATA, a provider of digital healthcare IT solutions and services for wound management, announced today that the company’s Diabetic Foot Ulcer & Amputation Prevention solution was named as a semifinalist in the T1D Exchange 2018 Diabetes Innovation Challenge. Corstrata was one of 30 semifinalists chosen from academic researchers and early stage companies from around the world that submitted entries for solutions to support advanced diabetes care. T1D Exchange is a nonprofit research and collaboration organization dedicated to accelerating novel treatments to improve the care of people living with type 1 diabetes (T1D).

Diabetic foot ulcers (DFUs) are a common, limb-threatening, and expensive complication of diabetes. Of the 29M people with diabetes in the U.S., 1.7M suffer with one or more DFUs annually and 80K of these diabetics ultimately require an amputation. The risk of death at 5 years for DFU patients is 2.5 times as high as the risk for a patient with diabetes without a foot ulcer.

Corstrata offers a technology-enabled care management solution for diabetics at risk for formation of costly diabetic foot ulcers and related amputations. Using a “smart” mat to detect potential ulcers, Corstrata’s wound specialists engage with the patient through a mobile engagement app for timely intervention and prevention of ulcers. Corstrata’s Diabetic Foot Ulcer & Amputation Prevention Program serves as an outsourced end-to-end technology-enabled solution for value-based organizations and payers … read more

a pharmacist’s role in managing diabetes and foot ulcers

Stepping Up: A Pharmacist’s Role in Managing Diabetes and Foot Ulcers

The South African Pharmaceutical Journal highlights the critical role pharmacists play in the management of diabetes and associated complications, such as foot ulcers. The article emphasizes the importance of pharmacists in early detection, patient education, and interdisciplinary collaboration to prevent and manage diabetic foot ulcers (DFUs).

Key Highlights:

Early Detection: Pharmacists are often the first point of contact and can identify early signs of foot complications, facilitating prompt referrals.

Patient Education: Through counseling, pharmacists can educate patients on foot care practices, glycemic control, and the importance of regular check-ups.

Interdisciplinary Collaboration: Working alongside healthcare providers, pharmacists contribute to comprehensive care plans, ensuring optimal patient outcomes.

Medication Management: Pharmacists play a pivotal role in managing medications, monitoring for side effects, and ensuring adherence to treatment regimens.

The article underscores the evolving role of pharmacists from traditional dispensers to integral members of the healthcare team, particularly in chronic disease management and complication prevention.

Read the full article on the South African Pharmaceutical Journal website.

Keywords:
Pharmacist role in diabetes,
Diabetic foot ulcers,
Patient education in diabetes,
Interdisciplinary care

Diabetic Foot Disease: Current Challenges, Emerging Concepts and Future Directions

Diabetic Foot Disease: Current Challenges, Emerging Concepts and Future Directions

Summary: This open MDPI Topic Collection highlights diabetic foot disease as a major diabetes complication, with 19–34% lifetime risk of foot ulcers and 9–26 million new cases annually worldwide. It leads to lower-limb amputations, reduced quality of life, high healthcare costs, and mortality rates comparable to many cancers. While much research focuses on acute ulcer and infection management, significant gaps remain in prevention, recurrence, long-term outcomes, multidisciplinary care models, health economics, and implementation science. The collection welcomes submissions on innovative diagnostics, prevention strategies, patient-centered care, and emerging paradigms to improve outcomes and sustainability of diabetic foot care systems.

Key Highlights:

Emphasizes prevention and long-term management beyond acute care

Calls for multidisciplinary approaches and implementation research

Addresses global burden including high amputation and recurrence rates

Open for submissions on diagnostics, economics, and novel therapies

View topic collection

Keywords: diabetic foot disease, DFU prevention, multidisciplinary foot care

Usefulness of Procalcitonin in Diagnosing Diabetic Foot Osteomyelitis: A Pilot Study

Infected diabetic foot is the leading cause of hospital admissions for people with diabetes mellitus. Diabetic foot osteomyelitis (DFO) causes high morbidity and significant mortality. Current diagnostic tests for DFO are either expensive, invasive, or of low diagnostic yield. Objective. The objective of the study was to determine whether serum levels of procalcitonin (PCT), an inflammatory marker, differ between DFO and diabetic foot ulcers without osteomyelitis (ie, cellulitis) as controls. The authors also aimed to assess the usefulness of PCT in diagnosing DFO. Methods. A case-control study was designed comparing DFO with diabetic foot cellulitis as the control. Patients were classified as having osteomyelitis and cellulitis based on the International Working Group on the Diabetic Foot diagnostic criteria. Serum inflammatory markers PCT, adiponectin, C-reactive protein-1, osteoprotegerin (OPG), osteopontin (OPN), and interleukin … read more

Posted in Articles

Level of 25-hydroxyvitamin D and vitamin D receptor in diabetic foot ulcer and factor associated with diabetic foot ulcers

by admin on March 21, 2023

Predicting Success in Spinal Cord Stimulation for the Diabetic Foot

Predicting Success in Spinal Cord Stimulation for the Diabetic Foot: The Role of Infrared Thermography

Summary: This study (Bao et al., 2025) explored whether perioperative infrared thermography (IRT) can predict which patients with diabetic foot complications benefit most from spinal cord stimulation (SCS). Findings suggest that small changes in limb skin temperature after surgery may forecast long-term success in limb salvage.

Key Highlights:

Study cohort: 33 patients with diabetic foot complications underwent SCS.

Temperature changes: Patients whose skin temperature rose by ≥ –0.12 °C within one week of surgery achieved higher limb salvage rates.

Limb salvage outcomes: Overall, 78.8% of limbs treated with SCS avoided amputation.

Neuropathy factor: Success rate was lower in those with large-fiber neuropathy (59.1%) compared to patients without neuropathy (88.6%).

Ulcer grade: Severity of ulceration did not significantly predict outcomes.

Clinical significance: IRT offers a low-cost, non-invasive tool to identify patients most likely to benefit from SCS, improving patient selection and treatment planning.

Read the full article on Diabetic Foot Online

Keywords:
Bao,
spinal cord stimulation,
infrared thermography,
diabetic foot,
limb salvage

Heel Diabetic Foot Osteomyelitis: A Current Challenge in the Clinical Practice

Heel Diabetic Foot Osteomyelitis: A Current Challenge in the Clinical Practice

Summary: This retrospective observational study assessed outcomes of patients with diabetic foot osteomyelitis (DFO) managed in a specialized diabetic foot service between 2019 and 2022. Researchers compared patients with heel DFO to those with forefoot or midfoot DFO over a one-year follow-up, examining healing rates, healing time, amputation, and mortality.

Findings: Among 114 patients (mean age 67.9 years, 72.8% male, 91.2% type 2 diabetes), 30 had heel DFO and 84 had forefoot/midfoot DFO. Heel DFO patients exhibited more severe infection indicators, including larger ulcers (>5 cm), higher C-reactive protein levels, and greater prevalence of gangrene and peripheral arterial disease (PAD). Healing outcomes were significantly poorer for heel DFO cases, with longer healing times and higher rates of major amputation.

Healing rate: 66.7% (heel) vs 97% (forefoot/midfoot)

Healing time: 14 ± 6 weeks (heel) vs 6.8 ± 5 weeks (forefoot/midfoot)

Major amputation: 10% (heel) vs 0% (forefoot/midfoot)

Mortality: 6.6% (heel) vs 4.8% (forefoot/midfoot)

Multivariate analysis identified heel DFO and PAD as independent predictors of major amputation and non-healing. The study concludes that heel DFO represents a distinct clinical challenge associated with worse prognosis and slower recovery compared to other DFO sites.

Read full article

Keywords:
diabetic foot osteomyelitis,
heel ulcer,
diabetic foot ulcer,
amputation risk,
peripheral arterial disease

Enhancing Diabetic Foot Prevention: Global Guidelines and Questionnaire Tools

Enhancing Diabetic Foot Prevention: Global Guidelines and Questionnaire Tools

Summary: This systematic review examines international guidelines and validated questionnaire tools for diabetic foot screening (DFS), highlighting their role in preventing diabetic foot ulcers amid rising diabetes prevalence. It synthesizes core screening elements like neuropathy, vascular, and visual assessments, along with risk stratification models and screening frequencies, while identifying variations across guidelines and the potential of tools like Q-DFD and MNSI for accessible, self-managed prevention.

Key Highlights:

Core DFS components include monofilament testing for neuropathy, pedal pulse palpation for vascular status, and visual inspection for early ulcer signs.

Risk stratification categorizes patients as low-, moderate-, or high-risk, with screening intervals from annual to quarterly based on IWGDF and ADA guidelines.

Questionnaire tools such as Q-DFD and DFSQ-UMA enhance self-assessment and accessibility in diverse settings, reducing amputation risks.

Challenges involve guideline standardization and implementation in resource-limited areas; broader adoption by general practitioners could lower healthcare costs.

Read full article

Keywords:
diabetic foot screening,
diabetic foot ulcers,
risk stratification,
questionnaire tools,
wound healing prevention

Karnataka Leads National Push on Diabetic Foot Prevention with Launch of PRAIAS Initiative

Karnataka Leads National Push on Diabetic Foot Prevention with Launch of PRAIAS Initiative

Summary: Karnataka has launched the PRAIAS (Podiatry Reach Across India for Awareness and Screening) initiative at Gulbarga Institute of Medical Sciences in Kalaburagi to combat the rising burden of diabetic foot complications. Conceptualized by diabetic foot surgeons Dr. Sanjay Sharma and Dr. Pavan Belehalli and driven by FootSecure and StrideAide, the program features India’s first Digital Podiatry Screening Van equipped with advanced diagnostic tools. The mobile unit will travel across the country, focusing on underserved and remote areas to provide screening, awareness, and early intervention. Globally, a limb is lost every 20 seconds due to diabetes; in India, a new diabetic foot ulcer develops every 12 seconds. The initiative aims to reduce amputations through timely detection, education, and lifestyle management, with strong support from Karnataka’s Minister for Medical Education.

Key Highlights:

First-of-its-kind Digital Podiatry Screening Van for nationwide outreach

Focus on early detection and prevention in rural/underserved communities

Led by Dr. Sanjay Sharma and Dr. Pavan Belehalli; supported by FootSecure and StrideAide

Addresses alarming statistics: limb lost every 20 seconds globally due to diabetes

Read full article

Keywords: PRAIAS initiative, diabetic foot prevention, screening van, Sanjay Sharma

Smartphone-based infrared camera accurately detects diabetic foot ulcers

medwireNews: A low-cost, smartphone-based infrared (IR) camera works as well as a high-end IR camera for the detection of diabetic foot ulcers (DFU), study findings indicate … “An advanced home assessment tool to monitor the foot in people with diabetes is desirable, and for this measurement of foot skin temperature is a promising modality,” Rob van Doremalen (University of Twente, Enschede, the Netherlands) and co-authors explain … They acquired plantar images of both feet from 32 participants (mean age 67 years, 75% men) with a current (n=28) or recently healed (n=4) DFU using the FLIR-One IR camera (FLIR Systems, Wilsonville, Oregon, USA) attached to a Motorola XT1642 Moto G4 Plus smartphone (Motorola Mobility LLC, Chicago, Illinois, USA) … read more

LeucoPatch system for the management of hard-to-heal diabetic foot ulcers

in the UK, Denmark, and Sweden: An observer-masked, randomised controlled trial

The LeucoPatch device uses bedside centrifugation without additional reagents to generate a disc comprising autologous leucocytes, platelets, and fibrin, which is applied to the surface of the wound. We aimed to test the effectiveness of LeucoPatch on the healing of hard-to-heal foot ulcers in people with diabetes … This was a multicentre, international, observer-masked, randomised controlled trial of people with diabetes and a hard-to-heal foot ulcer done in 32 specialist diabetic foot clinics in three countries (UK, Denmark, and Sweden). After a 4-week run-in period, those with a reduction in ulcer area of less than 50% were randomly allocated (1:1) by computer-generated, web-based randomisation … read more

Read the full article on The Lancet Diabetes & Endocrinology

LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in

the UK, Denmark, and Sweden: an observer-masked, randomised controlled trial

The LeucoPatch device uses bedside centrifugation without additional reagents to generate a disc comprising autologous leucocytes, platelets, and fibrin, which is applied to the surface of the wound. We aimed to test the effectiveness of LeucoPatch on the healing of hard-to-heal foot ulcers in people with diabetes … Methods … This was a multicentre, international, observer-masked, randomised controlled trial of people with diabetes and a hard-to-heal foot ulcer done in 32 specialist diabetic foot clinics in three countries (UK, Denmark, and Sweden). After a 4-week run-in period, those with a reduction in ulcer area of less than 50% were randomly allocated … read more

FDA approves shock wave device for treatment of diabetic foot ulcers

Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection … read more

Responsive insole could prevent diabetic foot ulcers

The team is led by Muthu Wijesundara, principal research scientist and head of the Division of Biomedical Technologies at the University of Texas at Arlington Research Institute (UTARI). Their dual-layer insole apparatus for diabetic foot lesion prevention is based on technology developed in partnership with the University of North Texas Health Science Center.

Due to numbness in their legs and feet, people with diabetes are often unable to detect and respond to stress-related pain by adjusting their foot loading. This can result in repeated stress to high-pressure foot regions such as the heel or toes, and can worsen blisters, sores and ulcers to the point of severe tissue loss, amputation and even life-threatening infection … read more

Probiotics accelerate wound healing in patients with diabetic foot ulcer

Patients with diabetic foot ulcer (DFU) who were given probiotic supplements for 12 weeks had faster wound healing and improved glycemic control compared with similar patients on placebo, according to researchers who recently published their results in Diabetes/Metabolism Research and Reviews.

Diabetic foot ulcers healed faster in patients given probiotics.

“Due to the increasing global antimicrobial drug resistance issues, the idea of probiotic consumption is interesting and pertinent because probiotics have the ability to strengthen the immune system, have anti-inflammatory effects, and therefore, could increase the wound healing process,” wrote lead co-author Zatollah Asemi, PhD … read more

Topical Cream Effective Against Diabetic Foot Ulcers

A topical cream that helps regulate macrophage activity was effective in treating diabetic foot ulcers, a clinical trial reported.

In 236 patients with foot ulcers treated for 16 weeks, the proportion who had complete healing of the ulcer was significantly higher in the group randomized to receive the topical cream (60.7%) versus a comparator group treated with absorbent dressing (35.1%; OR 2.84, 95% CI 1.66-4.84, P<0.001), said Shun-Cheng Chang, MD, of the Taipei Medical University in Taiwan, and colleagues … read more

Diabetic foot ulcers heal quickly with nitric oxide technology

Diabetic foot ulcers can take up to 150 days to heal. A biomedical engineering team wants to reduce it to 21 days … They’re planning to drop the healing time by amplifying what the body already does naturally: build layers of new tissue pumped up by nitric oxide. In patients with diabetes, impaired nitric oxide production lessens the healing power of skin cells and the Centers for Disease Control reports that 15 percent of Americans living with type II diabetes struggle with hard-to-heal foot ulcers. However, simply pumping up nitric oxide is not necessarily better. The long-term plan of Michigan Technological University …. read more

LeucoPatch helps heal diabetic foot ulcers faster

A new system that uses a multilayer patch made with a patient’s own leukocytes, platelets, and fibrin can speed the healing of diabetic foot ulcers, according to new findings … “The use of LeucoPatch is associated with significant enhancement of healing of hard-to-heal foot ulcers in people with diabetes,” Dr. Frances Game of Derby Teaching Hospitals NHS Foundation Trust in the UK and colleagues conclude in The Lancet Diabetes & Endocrinology online September 19 report … read more

ViroMed Gene Therapy for Non-Healing Diabetic Foot Ulcers Starts Phase III Trial

The first patient has been dosed in a Phase III trial assessing ViroMed’s VM202, the first pivotal study of a gene therapy indicated for patients with nonhealing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD).

The Phase III trial (NCT02563522) is a double-blind, placebo-controlled, multicenter study designed to evaluate VM202 for safety and efficacy in 300 adults with a diabetic foot ulcer and concomitant PAD. Two hundred patients will be randomized to VM202 and the other 100 to placebo, ViroMed’s U.S. division VM BioPharma said yesterday. … read more

Researchers develop footwear technology to prevent diabetic foot ulcers

To prevent diabetic foot ulcers, research scientists at The University of Texas at Arlington have developed footwear technology that relieves pressure on areas of the feet that experience high stress during walking and other activities … Muthu Wijesundara, principal research scientist and head of the Division of Biomedical Technologies at the University of Texas at Arlington Research Institute (UTARI), and his team have received a patent from the United States Patent and Trademark Office for a dual-layer insole apparatus for diabetic foot lesion prevention. The technology was developed in partnership with the University of North Texas Health Science Center … read more

Influence of Foot Ulceration on All-Cause and Cardiovascular Mortality in Diabetic Patients

PURPOSE:
The purpose of this study was to analyze the influence of a diabetic foot ulcer on all-cause and cardiovascular disease (CVD) mortality.

DESIGN:
Retrospective case-control study.

SUBJECTS AND SETTING OUTPATIENTS:
Eighty-eight patients with new-onset diabetic foot ulceration (DFU) were paired with 176 patients without DFU (controls). The study setting was the Department of Endocrinology, Sun Yat-sen Memorial Hospital, located in Guangzhou, China.

METHODS:
Cause-specific mortality was recorded during a median follow-up duration of 6.20 years up to 1 March 2016. Records review dates were from January 1, 2004, to December 31, 2010.

… read more

Activated PRP Plus Angioplasty Enhances Healing in Diabetic Foot Ulcers

Activated PRP Plus Angioplasty Enhances Healing in Diabetic Foot Ulcers, suggests study

Summary: Reporting on new evidence from the World Journal of Diabetes, this piece highlights improved DFU healing when vascular intervention (angioplasty) is paired with activated PRP. The dual strategy targets ischemia and tissue regeneration, though authors call for larger randomized trials to standardize PRP protocols.

Key Highlights:

Combination therapy: revascularization + biologic (activated PRP).

Enhanced wound-closure metrics compared to single-modality care.

Clinical rationale: restore perfusion and stimulate local tissue repair.

Next steps: standardize PRP activation, dosing, frequency in RCTs.

Read full article

Keywords: PRP, angioplasty, diabetic foot ulcer, World Journal of Diabetes, Huang

Continuous Glucose Monitoring and Diabetic Foot Ulcers

Continuous Glucose Monitoring and Diabetic Foot Ulcers: Is it Time to Walk in Range? A Brief Narrative Review

Summary: 2026 brief narrative review summarizes evidence on continuous glucose monitoring (CGM) in diabetic foot ulcer (DFU) management. Both hypo- and hyperglycemia delay healing and raise mortality; CGM outperforms self-monitoring for control. Emerging data indicate CGM-derived metrics like time in range (TIR) may promote wound healing by stabilizing glucose, reducing complications. Positions CGM as promising for DFU outcomes and amputation prevention, but notes need for well-designed trials to confirm benefits and inform clinical guidelines.

Key Highlights:

Evidence: CGM enhances control; glucose extremes impair repair.

Potential: TIR optimization for healing acceleration.

Call: Trials needed for everyday use in DFU care.

Relevance: Complements prevention (AI screening) and advanced therapies by addressing systemic glycemic factors in hard-to-heal DFUs.

Read full review (subscription may be required)

Keywords: continuous glucose monitoring, DFU management, time in range, glycemic control

Diabetic Foot Ulcers: Offloading, Surgery, and Beyond

Diabetic Foot Ulcers: Offloading, Surgery, and Beyond

Summary: At SAWC Spring 2026, Dr. Paul Kim and Dr. Johanna-Marie Richey delivered a practical, high-yield session on DFU management. They emphasized moving beyond simple wound closure to address underlying biomechanical abnormalities, perfusion, infection, and patient-specific factors. Key themes included thorough biomechanical evaluation (gait, deformities, joint ROM, weight-bearing imaging), distinguishing sagittal vs. shear forces, prioritizing non-operative offloading, and using surgery selectively to correct deformity and redistribute pressure. Minor amputations should be viewed as part of a limb-preservation strategy focused on function and preventing major amputation.

Key Highlights:

Biomechanics is a primary driver of DFU development and recurrence

Non-operative offloading remains first-line; surgery is reserved for correctable deformities

Flexor tenotomy, metatarsal osteotomies, and Achilles lengthening discussed as targeted options

Goal: stable, functional residual limb with low reulceration risk

Authors/Speakers: Paul Kim, DPM, MS & Johanna-Marie Richey, DPM

Read full article

Keywords: DFU offloading, diabetic foot surgery, biomechanical assessment, Paul Kim DPM

FibroBiologics Announces Release of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

FibroBiologics Announces Release of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

Summary: FibroBiologics, Inc. announced the successful release and shipment of the first clinical batch of CYWC628, its fibroblast-based spheroid therapeutic candidate, for the upcoming Phase 1/2 trial in patients with diabetic foot ulcers (DFU). This milestone positions the company to begin patient enrollment and dosing. CYWC628 aims to harness the regenerative power of fibroblasts to improve healing in chronic DFUs.

Key Highlights:

First GMP batch of CYWC628 released and shipped for clinical use

Phase 1/2 trial in DFU patients now imminent

Novel fibroblast spheroid approach targeting regenerative wound healing

Part of broader platform with 270+ patents in regenerative medicine

Read full announcement

Keywords: CYWC628, FibroBiologics DFU, fibroblast spheroids

FibroBiologics Announces Release of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

FibroBiologics Announces Release of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

Summary: FibroBiologics has successfully manufactured and released the first clinical batch of CYWC628, its novel fibroblast-based spheroid therapeutic candidate. This milestone enables the start of patient enrollment in the Phase 1/2 clinical trial for diabetic foot ulcers (DFU). The company aims to leverage the regenerative potential of fibroblasts to improve healing in chronic, hard-to-heal DFUs.

Key Highlights:

First GMP batch of CYWC628 released and ready for clinical use

Phase 1/2 DFU trial imminent with patient dosing expected soon

Novel spheroid technology targeting regenerative wound repair

Part of FibroBiologics’ broader regenerative medicine platform

Read full announcement

Keywords: CYWC628, FibroBiologics DFU, fibroblast spheroid

Shoe Insole May be a Help for Patients with Diabetic Foot Ulcers

Diabetic ulcers commonly result from high blood sugar damaging nerves, which takes away feeling from the toes or feet … Without the ability to feel pain, hits and bumps tend to go unnoticed and skin tissue breaks down, forming ulcers … A lot of sugar in the bloodstream, along with dried skin as a consequence of diabetes, further slow the ulcer healing process … Recently, Purdue researchers developed a shoe insole that could help make the healing process more portable for the 15% of Americans who develop ulcers as a result of diabetes … The researchers used lasers to shape silicone-based rubber into insoles, and then create reservoirs that release oxygen only at the part of the foot where the ulcer is located … read more

‘Smart’ Insoles Reduce Diabetic Foot Ulcer Recurrence

BERLIN — Wearing pressure-sensing smart insoles (SurroSense Rx, Orpyx Medical Technologies) reduced diabetic foot ulcer recurrence by up to 86% in compliant patients in a randomized single-blinded trial in high-risk individuals with type 1 and 2 diabetes … Neil Reeves, PhD, professor of musculoskeletal biomechanics, Manchester Metropolitan University, UK, presented the results here today at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting …“By using a plantar pressure-sensing smart insole device, the feedback of pressure information in the intervention arm reduces ulcer recurrence by 71%, and furthermore in the compliant patients, this further increased benefit, with an 86% reduction in ulcer recurrence [compared with controls],” he reported … read more

Management of an open crush fracture to the foot from a lawnmower injury: A case report

Management of an Open Crush Fracture to the Foot from a Lawnmower Injury: Case Report

This case report from *The Foot & Ankle Online Journal* (December 2020) details the clinical journey of a patient sustaining a high-energy open crush fracture to the mid- and forefoot—caused by a lawnmower. The report highlights key steps in surgical, infection-control, and rehabilitation management within an evidence-based framework.

Case Overview:

Injury Description: The patient presented with an open fracture involving multiple metatarsals and cuneiforms, with accompanying soft-tissue loss and heel pad damage—characteristic of high-energy lawnmower trauma.

Initial Management Steps: Following Advanced Trauma Life Support principles, the patient underwent emergent irrigation and debridement, broad-spectrum intravenous antibiotics within one hour, tetanus prophylaxis, and limb stabilization with Kirschner-wires and external fixation.

Surgical Reconstruction: Multiple staged procedures addressed wound cleaning, fracture alignment, and repair of soft tissue avulsions, using a combination of hardware and meticulous technique to preserve tissue viability and prevent infection.

Infection Prevention Strategy: Aggressive decontamination, serial debridement, and appropriate antimicrobial coverage for both anaerobic and aerobic pathogens—including Pseudomonas and Staph aureus—were employed to reduce osteomyelitis risk.

Rehabilitation Approach: A structured physiotherapy program was initiated early, focusing on range-of-motion, strengthening, edema control, and gradual weight-bearing to restore function and reduce stiffness.

Clinical Takeaways:

High-risk open crush injuries require immediate, protocol-driven intervention to minimize complications like infection and non-union.

Staged surgical treatment—balancing infection control, mechanical stability, and soft tissue preservation—is essential for optimal outcomes.

Early rehabilitation plays a key role in functional recovery and reducing long-term morbidity.

This illustrative case underscores the critical value of a multidisciplinary, evidence-based approach when managing severe foot trauma from lawnmower injuries.

Keywords: open fracture, crush injury, lawnmower trauma, debridement, Kirschner‑wire fixation, antibiotic prophylaxis, physiotherapy rehabilitation

Read the full case report on FAOJ

Identifying and treating foot ulcers in patients with diabetes

saving feet, legs and lives

There has been a great deal of debate around diabetic foot ulcers (DFUs) and pressure ulcers (PUs) on the feet of patients with diabetes, in terms of how to define, detect, assess and treat them. The confusion and lack of evidence in differentiating between these two types of foot ulcers, particularly on the heel, can lead to misdiagnosis, which can increase both financial and patient-related costs.

To address and tackle those inconsistencies, the Journal of Wound Care (JWC) has published its first international consensus document, Identifying and treating foot ulcers in patients with diabetes: saving feet, legs and lives. The main objectives of this project were to:

Provide information on the differences between a DFU and a PU in patients with diabetes

Help reduce misdiagnosis by providing and discussing assessment guidelines

Make a difference in practice through improved patient outcomes.

With this in mind, an international panel of ten key opinion leaders from Australia, England, Republic of Ireland, Malaysia, Poland, Portugal, Spain, United Arab Emirates and US met on 1 and 2 March 2018 in London. They discussed the definitions of a DFU and a PU, and concluded that one way to distinguish between them is knowing whether the patient is mobile (usually associated with DFUs) or immobile (normally related to PUs), although this should be considered along with simple assessments for ischaemia and neuropathy. To this end, and given the importance of an early and correct assessment, the mnemonic ‘VIPS’ was suggested:

V: vascular (ischaemia)

I: infection (local signs, odour, exudate, slough, inflammation, etc.)

P: pressure (causes mobility or immobility)

S: sensation (neuropathy).

read more

‘Foot Selfies’ May Improve Remote Diabetic Foot Monitoring

“Foot selfies” may be a simple solution to keeping tabs on patients at high risk for diabetic foot complications.

Patients with or at risk of foot ulcers are told to check their feet regularly at home, but doing so can be difficult for those who aren’t flexible or who have vision problems. Those who live alone may not be able to ask someone else to check their feet for them. Some use hand mirrors, but those can be difficult to manipulate and don’t offer feedback … read more

The management of diabetic foot

A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine.

Major Recommendations
Definitions of the strength of the recommendations (Grade 1 or 2) and quality of the evidence (Level A–C) are provided at the end of the “Major Recommendations” field.

Prevention of Diabetic Foot Ulcers (DFUs)

1. The committee recommends that patients with diabetes undergo annual interval foot inspections by physicians (MD, DO, DPM) or advanced practice providers with training in foot care (Grade 1C).

2. The committee recommends that foot examination include testing for peripheral neuropathy using the Semmes-Weinstein test (Grade 1B).

3. The committee recommends education of the patients and their families about preventive foot care (Grade 1C).

4a. The committee suggests against the routine use of specialized therapeutic footwear in average-risk diabetic patients (Grade 2C).

4b. The committee recommends using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation (Grade 1B).

5. The committee suggests adequate glycemic control (hemoglobin A1c <7% with strategies to minimize hypoglycemia) to reduce the incidence of DFUs and infections, with subsequent risk of amputation (Grade 2B).

6. The committee recommends against prophylactic arterial revascularization to prevent DFU (Grade 1C).

Off-Loading DFUs

1. In patients with plantar DFU, the committee recommends offloading with a total contact cast (TCC) or irremovable fixed ankle walking boot (Grade 1B).

2. In patients with DFU requiring frequent dressing changes, the committee suggests off-loading using a removable cast walker as an alternative to TCC and irremovable fixed ankle walking boot (Grade 2C). The committee suggests against using postoperative shoes or standard or customary footwear for off-loading plantar DFUs (Grade 2C).

3. In patients with nonplantar wounds, the committee recommends using any modality that relieves pressure at the site of the ulcer, such as a surgical sandal or heel relief shoe (Grade 1C).

read more

An AI Chatbot for Diabetic Foot Remission Following Limb Reconstruction

Dosing Walking Like a Drug: An AI Chatbot for Diabetic Foot Remission Following Limb Reconstruction

Summary: This protocol paper outlines a conversational AI chatbot designed to guide diabetic foot remission after wound healing or limb reconstruction by treating walking and therapeutic footwear as titratable “drugs.” The system integrates daily data (step counts via phone/wearable, paired foot skin temperature differences, shoe wear time, and symptom checks) to assign risk tiers (green/amber/red) and deliver personalized next-day guidance. Activity advances gradually (~500 steps/week) while gated by thermometry (hold/reduce if ≥2.2°C side-to-side difference). Footwear progression starts conservatively and escalates only with stable skin checks. Built on prior SmartBoot sensor work, the single-arm feasibility pilot (n=30) will assess engagement, safety, and implementation before larger trials. The approach aims to bridge the high-relapse gap (up to 40% within a year) through structured, data-driven home monitoring.

Key Highlights:

AI chatbot titrates walking (~500 steps weekly increments) and footwear based on real-time thermometry and sensors

2.2°C temperature difference threshold triggers de-escalation and clinical escalation if persistent

Addresses 40% recurrence risk with precise, responsive remission guidance

Authors/key contributors: Lucian Feraru, David Klonoff, Bijan Najafi et al.

Read full protocol article

Keywords: AI chatbot diabetic foot, diabetic foot remission, walking dosing, Bijan Najafi

The Role of Early Revascularization and Biomarkers in the Management of Diabetic Foot Ulcers

A Single Center Experience

Diabetic neuropathy and Peripheral Arterial Disease (PAD) are the main etiological factors in foot ulceration. Herein, we report our experience of diabetic foot ulceration (DFU) management, with an analysis of the relationship between the rate of lower extremity amputation, in persons with infected DFU, after revascularization procedures performed to prevent major amputation. This study highlights the role of different biomarkers, showing their usefulness and potentiality in diabetic foot ulcer management, especially for the early diagnosis and therapy effectiveness monitoring. A retrospective analysis, from September 2016 to January 2021, of diabetic patients presenting diabetic foot with DFU, was performed. All patients were treated with at least one vascular procedure (endovascular, open, hybrid procedures) targeting PAD lesions … read more

Patient Engagement, Diabetes and Diabetic Foot Ulcers | EWMA Podcast

In this episode, you can listen to a conversation between the EWMA Podcast Host Samantha Holloway and Dr Athanasios Hassoulas, director of the MSc in Psychiatry programme and Senior Lecturer in Psychological Medicine at Cardiff University. They will talk about the meaning and impact of patient engagement and empowerment in relation to diabetes and diabetic foot ulcer management. The podcast provides reflections on the topic as well as recommendations on how to implement these person-centred tools in your meetings with diabetic foot ulcer patients in you daily clinical practice … listen

Medicinal Plants as Efficacious Agents for Diabetic Foot Ulcers: A Systematic Review of Clinical Studies

A diabetic foot ulcer (DFU) is a chronic, nonhealing wound that occurs in approximately 15% to 25% of patients with diabetes, and amputation is necessary in approximately 5% to 24% of these patients. Medicinal plants have demonstrated promising wound healing activities in animal models of DFUs as well as in clinical studies. These plants, which are described as medicinal in different regions of the world, are not considered to be standard medicinal treatments in Western medicine at this time. Some medicinal products, such as bromelain—an herbal protease currently used for enzymatic debridement of wounds—have been obtained from plants, showing the important role of these natural products as sources of wound healing agents. This paper aims to review clinical studies on the effects of medicinal plants in patients with DFUs based on the improvement of local and systemic parameters related to wound healing. Electronic databases including PubMed, Scopus, and Cochrane Library were searched for studies from inception through May 2019 using the keywords “diabetic foot ulcer” … read more

Intensive glycemic control may prevent diabetic foot ulcers

medwireNews: Early intensive glycemic control may reduce the long-term risk for foot ulcers in people with type 1 diabetes, suggest data from the Diabetes Control and Complications Trial (DCCT) and Epidemiology of Diabetes Interventions and Complications (EDIC) study … The DCCT included 1408 people with type 1 diabetes who completed an average of 6.5 years of intensive (target glycated hemoglobin [HbA1c] <6.05% [42.6 mmol/mol]) or conventional (no specific glycemic target) diabetes treatment and subsequently underwent 23 years of follow-up in the EDIC study … During this period, 195 participants developed at least one diabetic foot ulcer (48 people had multiple events) and 36 needed lower extremity amputation … read more

Nutrition Interventions in Adults with Diabetic Foot Ulcers

Diabetic foot ulcers (DFU) are chronic wounds in the foot or feet associated with neuropathy and/or peripheral artery disease (PAD) of the lower limb in patients with diabetes mellitus.

Reports from the Centers for Disease Control and Prevention show that in the United States there are nearly one in four adults living with diabetes, which indicates that a large number of Americans are at risk of DFU.

DFUs will develop in up to 34% of patients with diabetes at some time in their lives, and of those, approximately 15%–25% will require an amputation.

Moderate or severe malnutrition has been identified in over half of patients with DFU, and malnutrition in DFU is correlated with increased lower-extremity amputation.

… read more

Nutrition Interventions in Adults with Diabetic Foot Ulcers

Diabetic foot ulcers (DFU) are chronic wounds in the foot or feet associated with neuropathy and/or peripheral artery disease (PAD) of the lower limb in patients with diabetes mellitus. Reports from the Centers for Disease Control and Prevention show that in the United States there are nearly one in four adults living with diabetes, which indicates that a large number of Americans are at risk of DFU. DFUs will develop in up to 34% of patients with diabetes at some time in in their lives, and of those, approximately 15%–25% will require an amputation. Moderate or severe malnutrition has been identified in over half of patients with DFU, and malnutrition in DFU is correlated with increased lower-extremity amputation. Improvements in wound care therapy, including nutrition interventions, can reduce the financial burden of DFUs and increase life expectancy and quality of life … read more

Angiosome-guided endovascular revascularization for treatment of diabetic foot ulcers

with peripheral artery disease
Because diabetic foot ulcers (DFUs) are difficult to heal and cause huge economic losses to society, accelerating their healing has become extremely important. The purpose of this study was to evaluate the effect of revascularization based on the angiosome concept on DFU … Between January 2018 and July 2020, 112 consecutive legs with DFUs in 111 patients who were discharged from the vascular surgery department of our hospital were retrospectively evaluated. The legs were assigned to two groups depending on whether direct arterial flow to the foot ulcer based … read more

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Efficacy and Safety of Topical Solution of Diperoxochloric Acid for Neuropathic Diabetic Foot Ulcer

Results from a Phase 3, Multicentre, Randomized, Active-controlled, Parallel-group Study

Diabetic foot ulcer (DFU), if untreated, accounts for lower-limb amputations affecting patients’ quality-of-life. Diperoxochloric acid (DPOCL) is known to heal DFU by its antibacterial and fibroblast stimulating activity. This was a phase 3, multicentre, randomized, double-blind, active-controlled, parallel-group study conducted to evaluate the efficacy and safety of topic solution of DPOCL compared with isotonic sodium chloride solution (ISCL). Adult patients with type 1 or 2 diabetes with random blood glucose levels of <250 mg/dL, with ≤ than three full-thickness foot ulcers were enrolled. Primary efficacy endpoint was complete wound closure and secondary was wound surface area. Adverse events were analyzed as safety endpoint. Of 311 enrolled patients, 289 were randomized … read more

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Nutrition Interventions in Adults with Diabetic Foot Ulcers

Diabetic foot ulcers (DFU) are chronic wounds in the foot or feet associated with neuropathy and/or peripheral artery disease (PAD) of the lower limb in patients with diabetes mellitus.

Reports from the Centers for Disease Control and Prevention show that in the United States there are nearly one in four adults living with diabetes, which indicates that a large number of Americans are at risk of DFU.

DFUs will develop in up to 34% of patients with diabetes at some time in in their lives, and of those, approximately 15%–25% will require an amputation.

Moderate or severe malnutrition has been identified in over half of patients with DFU, and malnutrition in DFU is correlated with increased lower-extremity amputation.

Improvements in wound care therapy, including nutrition interventions, can reduce the financial burden of DFUs and increase life expectancy and quality of life.

… read more

Vitamin D deficiency increases risk for diabetic foot ulcer

Adults with diabetes and severe vitamin D deficiency are three times more likely to develop a diabetic foot ulcer than similar patients with sufficient vitamin D levels, according to findings from a meta-analysis published in Nutrition & Diabetes … “Vitamin D has been suggested to play an important role in many chronic diseases, such as diabetes,” Yimin Chai, MD, PhD, professor in the department of orthopedic surgery at Shanghai Jiao Tong University, China, and colleagues wrote. “Low serum vitamin D levels are associated with insulin resistance, impaired beta-cell function and the development of [diabetes]. There is also ongoing interest in the association between lower level of vitamin D and diabetic complications.” … read more

Malnutrition in type 2 diabetic patients does not affect healing of foot ulcers

Protein–energy malnutrition is known to be involved in wound healing. While wound healing in patients with diabetic foot ulcers (DFU) is a complex and multifactorial process, the role of malnutrition in this case has rarely been explored. The objective of this study was to determine whether the nutritional status of diabetic patients influences the healing of DFU … 48 patients were included in this prospective, single-center study. All patients with comorbidities or factors involving malnutrition or influencing biological measurements were excluded. Patients were followed up for 24 weeks … read more at Acta Diabetologica (purchase required)

India uses 4D bioprinting for diabetic foot ulcer management

Indian pharmaceutical firm Alkem Laboratories has announced to launch a unique patented technology for the treatment of Diabetic Foot Ulcer (DFU). The solution would be based on disruptive 4D Bioprinting technology, which would be used to treat deep, non-healing chronic wounds and is expected to be launched in the Indian market in the latter half of 2022 post regulatory approval … This advanced technology for DFU management has a high scope of preventing amputations in diabetic patients. This technology will be available at affordable rates to Indian patients at a time when there is no definitive treatment for DFU in India … read more

LinkedIn:
Alkem Laboratories

Multiple factors predict longer and shorter time-to-ulcer-free in people with diabetes-related foot ulcers

Survival analyses of a large prospective cohort followed-up for 24-months
Researchers aimed at determining the factors that are independently linked with time-to-(being)-ulcer-free, time-varying effects and predict adjusted ulcer-free probabilities, in a large prospective cohort with diabetes-related foot ulcers (DFU) followed-up for 24 months … read more

Posted in Articles

Disposable Slippers Enhanced with Medical Wound Care Technology

by admin on May 9, 2023

…causing foot warts, athlete’s foot, Staphylococcus skin infection, nail fungal infection to name a few are bacterial, fungal, and viral in origin. Passive disposable slippers of varying quality are commonly…

Amputation-free survival in 17,353 people at high risk for foot ulceration

in diabetes: A national observational study

Diabetic foot ulcers and amputations are devastating and much feared complications of diabetes. Between 15% and 34% of people with diabetes develop a foot ulcer during their lifetime, with more than half acquiring infections that may result in lower extremity amputations causing disability, extensive periods of hospitalisation, and premature mortality. The incidence of major amputation ranges from 0·2 to 2·0 per 1000 people in those with diabetes. Major or minor amputation also increases the risk of additional subsequent amputations. Foot ulcers are the costliest microvascular complication of diabetes … Amputations in people with diabetes have a significant impact on ambulation, body care, movement and mobility, resulting in an inability to perform daily tasks and often a loss of employment impacting on the wider family. Clinical epidemiology studies suggest that foot ulcers precede around 85% of non-traumatic lower extremity amputations in individuals with diabetes [8] and hence ulcer prevention is important. Previous studies have reported that apart from severity of ulcer, age [9], low socioeconomic status, smoking, sex, renal impairment, ischaemic heart disease, diabetic neuropathy, glucose levels and peripheral arterial disease are some of the important factors associated with the risk of amputation. Identifying a person’s risk of foot ulceration helps in directing scarce resources to those most at need. Assessment of individual risk factors … read more

Magnitude of Surgical Site Infections, Bacterial Etiologies, Associated Factors and Antimicrobial Susceptibility Patterns of

Isolates Among Post-Operative Patients in Harari Region Public Hospitals, Harar, Eastern Ethiopia
Surgical site infections (SSIs) are infections that occur one month after a surgical operation or one year after implant surgery and a surgical procedure, either at the injury site or near the injury site. Surgical site infections are still a major global problem, especially in developing countries, where they cause increased morbidity and mortality. There is a dearth of information regarding SSIs in the eastern Ethiopia, particularly in this study area … read more

Lumicell Launches Wound Care Infection and Perfusion Division

WELLESLEY, Mass.–(BUSINESS WIRE)–Lumicell, Inc., a leader in the field of image-guided cancer surgery, today announced that it has created a new division to drive the expansion of its pioneering technologies to include wound care, infection and perfusion.

According to a recent study in the Journal of The International Society for Pharmacoeconomics and Outcomes Research, each year in the U.S. there are about 8.2 million patients being treated under Medicare for chronic wounds with an estimated cost between $31.7 to $96.8 billion per year1. With the rising prevalence of obesity-related diseases, such as diabetes, and an aging population – there continues to be a growth in the number of patients suffering from chronic wounds. And with healthcare professionals making care decisions based on the limited, evidence-based knowledge of wounds and requiring patients to make weekly visits to track progress, this upward trend is predicted to continue.

“Chronic wounds have a dramatic impact on affected individuals, their families and the U.S. Health Care System, leading to reduced quality of life, limb loss and loss of life at a significant financial cost,” said Robert S. Kirsner, M.D., PhD, FAAD, Director, University of Miami Hospital and Clinics Wound Center. “Unfortunately, wound care is often a largely overlooked medical need compared to other medical challenges like cancer, despite similar effects on loss of life. There is a need for new technologies to assess the state of a wound, integrate this with clinical data, and support the best treatment, for the right patient, at the right time.”

“We created our new wound care, infection and perfusion division for the same reason we launched our pioneering cancer technology — we identified a patient population in desperate need and decided to apply our technology and leverage our world-class team to help people suffering from chronic wounds,” said W. David Lee, CSO of Lumicell. “We believe the biggest healthcare engineering breakthroughs happen outside of the biology lab. As such, Lumicell’s new division will use concurrent engineering – the convergence of engineering and biological research – to accelerate the pace of biological discoveries and create new applications to diagnose and treat patients.”

“While it will require significant research and development, it will be well worth the effort,” Lee said. “Lumicell has already established the foundational technology for this forward-thinking approach and assembled a small group of advisors to guide the team through the first stages of development. Our goal is to better understand wound healing and on a molecular level and to create an unbiased, holistic protocol that blends Lumicell’s care-leading technology, artificial intelligence and informed care options.”

Lumicell also hopes to create a community of wound care experts, including doctors, nurses, researchers and insurance company executives who are interested in providing expertise, evidence, opinions and guidance. This community will curate the statistics, biology and science needed to ensure the infection and profusion detecting technologies and accompanying standard of care protocols are accessible and adopted across disciplines.

¹Samuel R. Nussbaum MD, Marissa J. Carter PhD MA, Caroline E. Fife MD, Joan DaVanzo PhD MSW, Randall Haught, Marcia Nusgart RPh, Donna Cartwright MPA. An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Journal of The International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Value in Health 21 (2018) 27-32

About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM System has unprecedented ability to see and remove cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers. For more information, please visit www.lumicell.com.

Contacts

For Lumicell
Ali Buckneberg, 612-334-5960
ali.buckneberg@wordsatwork.com

press release from BusinessWire

Antimicrobial Activity of Jatropha curcas Latex Against Cutaneous Wound and Burn Infections

Antimicrobial Activity of Jatropha curcas Latex Against Cutaneous Wound and Burn Infections

A recent study published in Infection and Drug Resistance explores the potential of Jatropha curcas latex as a topical antimicrobial for wound and burn care. The research team, led by Ali Salman Al‑Shami and Mokhtar Alzomor, investigated the plant’s latex against several antibiotic-resistant pathogens commonly implicated in skin infections.

Key Highlights:

Pathogens Tested: The study targeted Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Candida albicans.

Results: J. curcas latex demonstrated significant antimicrobial activity, producing inhibition zones as large as 31 mm for S. aureus and showing promising minimum inhibitory concentration (MIC) values ranging from 6.25 to 25 mg/mL.

Comparative Effectiveness: In many cases, the latex outperformed standard antibiotics like tetracycline and ofloxacin, suggesting potential as a natural alternative or adjunct therapy.

Mechanism: The latex contains bioactive compounds such as flavonoids, saponins, and tannins, which may contribute to its antimicrobial properties.

Conclusion: The authors conclude that Jatropha curcas latex holds promise as a broad-spectrum topical agent, especially in regions facing antibiotic resistance. Further in vivo research is needed to establish clinical safety and efficacy.

Keywords:
Ali Salman Al‑Shami,
Mokhtar Alzomor,
Jatropha curcas,
burn infections,
natural antimicrobials,
antibiotic resistance,
wound healing

Read the full article here

New combination drug therapy offers hope for treating chronic wound infections

Chronic Wound Infections: New Drug Therapy Hope

Summary: Scientists at the University of Oregon have identified a promising new therapy that combines low-dose chlorate with standard antibiotics to fight chronic wound infections. In laboratory tests against Pseudomonas aeruginosa, a common and stubborn wound pathogen, this combination improved antibacterial effectiveness by as much as 10,000-fold. The discovery could help restore the power of existing antibiotics, reduce treatment time, and minimize side effects for patients struggling with infected chronic wounds.

Key Highlights:

New mechanism: Chlorate disrupts bacterial nitrate metabolism in low-oxygen wound environments, making pathogens more susceptible to antibiotics.

Improved potency: Antibiotic efficacy increased dramatically, allowing for potential dose reductions.

Clinical potential: The approach may shorten treatment duration, improve outcomes, and reduce toxicity in patients with chronic wound infections.

Resistance relevance: This method could help combat antibiotic resistance by enhancing the effectiveness of existing drugs.

Next steps: Further research and human clinical trials are needed to determine safety, dosage, and real-world effectiveness.

Read the full article on Time.News

Keywords:
Melanie Spero,
University of Oregon,
chlorate,
antibiotic synergy,
Pseudomonas aeruginosa,
chronic wound infection

Flesh-Eating Bacteria Infections Are on the Rise in the US

Flesh-Eating Bacteria Infections Are on the Rise in the US

Summary: This article warns of the rising incidence of necrotizing fasciitis (“flesh-eating bacteria”) infections across the United States. Caused primarily by Group A Streptococcus and other aggressive pathogens, these rapidly progressing infections destroy soft tissue and can lead to sepsis, limb loss, or death if not treated immediately. High-risk groups include people with diabetes, chronic wounds, immunosuppression, or recent surgery/trauma. Emphasizes early recognition (severe pain out of proportion to visible signs, rapid swelling, bullae, crepitus) and urgent management: aggressive surgical debridement, broad-spectrum IV antibiotics, and supportive care. Highlights the importance of wound care vigilance and prompt referral in high-risk patients to improve survival rates.

Key Highlights:

Increasing cases of necrotizing fasciitis in the US

Rapid tissue destruction; high mortality without immediate intervention

Key risks: Diabetes, chronic wounds, immunosuppression

Management: Emergency debridement + antibiotics

Relevance: Critical awareness for wound care teams managing high-risk patients

Read article

Keywords: necrotizing fasciitis, flesh-eating bacteria, diabetic wound infection, emergency debridement

Guideline Adherence, Team Approach to Prevention Impacts Surgical Site Infections

Guideline Adherence, Team Approach to Prevention Impacts Surgical Site Infections

Summary:** This review of 20+ studies demonstrates that strict adherence to SSI prevention guidelines—antibiotic timing, normothermia, and hair removal—combined with multidisciplinary teams (surgeons, nurses, IPs) reduces infection rates by 25-40%. Post-discharge wound care education is crucial, as 50% of SSIs occur after hospital stay; tools like apps for monitoring improve compliance and outcomes in high-risk surgeries like orthopedic or vascular procedures.

Key Highlights:

Adherence Impact: 95% compliance lowers SSIs by 30%; gaps in post-op care contribute 60% of cases.

Team Benefits: MDT protocols cut re-admissions; nurse-led education boosts patient self-monitoring.

Post-Discharge: Digital tools for wound checks; patient guidance on hygiene and signs of infection essential.

Evidence: Meta-analysis of 15 RCTs; NNT 8 for guideline bundles.

Implications: Standardize education; integrate IPs for waste reduction in wound care.

Read full article

Keywords: SSI prevention, guideline adherence, multidisciplinary team, post-discharge care, surgical wounds

Perianal Infections in Patients With Hematologic Malignancy

The Risk of Fournier’s Gangrene Leading to Mortality and Irreversible Organ Damage
The efficacy of surgical intervention for perianal infection in patients with hematologic malignancy is not well-established. Objective. This article presents a case series of perianal infection progressing to Fournier’s gangrene (FG) in patients with hematologic malignancy to guide physicians, because to the author’s knowledge, there were no randomized or prospective studies presenting the management strategies reported herein. It was hypothesized that surgery might reduce mortality and morbidity in patients with inflammation spreading beyond the perianal region, in patients with abscess formation, and in those who show no improvement with medical therapy. Materials and Methods. The data of 4 adults with hematologic malignancy who developed perianal infection progressing to FG between January 2010 and December 2018 were reviewed retrospectively … read more

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Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety

Phase 1b Data for Topical Pravibismane in Diabetic Foot Ulcer Infection Demonstrates Favorable Effects and Safety

Abstract

Objective

Subjects and methods

Results

Conclusion

Introduction

Subjects and methods

Study design

Description of patients and collection of data

AM isolation, preservation, grafting, and follow-up of patients

Results

Demographic data of the sample

Results of the study

Table 1

Table 2

Table 3

Discussion

Conclusion

Recommendations and implications to practice

Footnotes

References

Phase 1b Results: Topical Pravibismane Shows Promise for Diabetic Foot Infections

The Role of Machine Learning in Infection Assessment of Diabetic Foot Ulcers: A Narrative Review

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What are the risk factors?

Boruta Algorithm–Guided Antibiotic Selection in Antibiotic-Loaded Bone Cement for Diabetic Foot Ulcers: Microbiota and Susceptibility Analysis

Mechanisms of microbial infection and wound healing in diabetic foot ulcer: pathogenicity in the inflammatory-proliferative phase, chronicity, and treatment strategies

Overview of Diabetic Foot Ulcers: Causes, Diagnosis, and Management

DFU-Helper: An Innovative Framework for Longitudinal Diabetic Foot Ulcer Diseases Evaluation Using Deep Learning

Prevention of Infection in Peripheral Arterial Reconstruction of the Lower Limb

Multifaceted Antibiotic Resistance in Diabetic Foot Infections: A Systematic Review

Healthcare‑Acquired Wound Infections & Antimicrobial Resistance: Embracing a Multidisciplinary Team Approach

The First Year of Remission: A Systematic Review and Meta-Analysis of 12-Month Diabetic Foot Ulcer Recurrence

Global Research Trends and Healthcare Innovations in Plantar Pressure Management for Diabetic Foot Ulcers: A 25-Year Bibliometric and Visual Analysis

Optimizing Diabetic Foot Ulcer Care: Four Steps to Save Limbs Worldwide

How New Technology Is Preventing Diabetic Foot Ulcers and Amputations

🔬 Spotlight: Temperature Monitoring and Predictive Tools for Diabetic Foot Ulcer Prevention

Classification of Diabetic Foot Ulcers

Mapping the Footprint of Progress: A Decade of Diabetic Foot Ulcer Research

AI-Powered Prediction of Postoperative Wound Infections in Diabetic Patients

Complications of Hospital-Acquired Wound Infections: Risks and Care Considerations

8-10pc of Diabetic Patients Develop Foot Ulcer Complications

Nutrition is not often the first thing clinicians think of when dealing with diabetic foot ulcers. How important is it, and exactly what role does nutrition play?

Clinical Trial Spotlight: Evaluating RGN-137 for Diabetic Foot Ulcers

Biodegradable Temporising Matrix in Diabetic Foot Ulcer Management

Medial Arterial Calcification & Diabetic Foot Ulcer Management

A Study to Evaluate the Safety and Efficacy of a Novel Wound Dressing in Patients With Diabetic Foot Ulcers

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers

FDA Approves dermaPACE® Shock Wave Device for Diabetic Foot Ulcers

Nagaland University Researchers Find Plant Compound to Treat Diabetic Wound Foot Ulcers

Development and Validation of a Diagnostic Nomogram for Wagner Grade ≥2 Diabetic Foot Ulcers in Patients with Diabetic Kidney Disease

Antibiotic-Loaded Bone Cement Significantly Improves Diabetic Foot Ulcer Outcomes: Systematic Review and Meta-Analysis

Negative Pressure Wound Therapy for Complicated Diabetic Foot Wounds

Revolutionising Diabetic Foot Care: A System in Urgent Need of Reform

High TEWL Predicts Diabetic Foot Ulcer Recurrence

Management of Diabetic Foot Ulcers Using Prontosan®: A Retrospective Case Series

Frailty Progression and Outcomes in Patients with Diabetic Foot Ulcers

Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial

Efficacy of Extracorporeal Shockwave Therapy in the Management of Chronic Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis

Smart Grey Wolf neural network (MGWONET): transforming diabetic foot ulcer analysis

Incidence of diabetic foot ulcer and its predictors among adult diabetes patients in Northern Ethiopia: a retrospective cohort study

Longevity Medical Institute Physicians and Scientists Publish Peer-Reviewed Research on Stem Cell Therapies for Diabetic Foot Ulcers

Mechanism of Action of Astragalus membranaceus for Treating Diabetic Foot Ulcers Based on Single-Cell RNA Sequencing Data and Network Pharmacology

Pilot Study Could Improve Treatment of Chronic Diabetic Foot Ulcers