235 search results for "topical pravibismane"

Successful Treatment of Moderately Ischaemic DFUs Using Intermittent Topical Oxygen

Summary: Published December 17, 2025 in the Diabetic Foot Journal (DiabetesontheNet), this article reports a post hoc analysis of a randomised, prospective, double-blind, sham-controlled study evaluating TWO2 — a cyclical pressurised topical oxygen therapy device — specifically in patients with moderately ischaemic diabetic foot ulcers (DFUs). This patient subset is clinically challenging because ischaemia restricts oxygen delivery to the wound bed, impairs cellular proliferation and angiogenesis, and substantially reduces response to standard care. Patients were adults with full-thickness, nonhealing DFUs (1–20 cm² post-debridement; University of Texas grade 1 or 2) present for 4 weeks to 1 year and failing at least 4 weeks of standard care. Moderate ischaemia was defined per IWGDF criteria as any of the following: ABI ≥ 0.7, TBI < 0.75, monophasic or biphasic Doppler waveforms below the knee, TcPO₂ < 60 mmHg, great toe pressure < 60 mmHg, or skin perfusion pressure < 60 mmHg. Following a 2-week run-in period, patients who had not responded were randomised to either an active TWO2 device or an identical-appearing sham device; all received standard foam dressings, below-knee off-loading (equivalent to total contact casting), and optimal standard care. At 12 weeks, 7 of 18 patients (39%) in the TWO2 arm achieved complete healing versus 0 of 18 patients (0%) in the sham arm (p = 0.0076). The authors propose a multimodal therapeutic rationale: TWO2 delivers up to 10 litres of oxygen per minute under cyclical pressure directly to the wound surface, establishing a steep diffusion gradient that drives oxygen into hypoxic tissue even in areas of poor perfusion. This is combined with non-contact compression and humidification. A notable implementation advantage is that the device can be self-administered by patients at home, avoiding the cost and logistical burden of daily specialist clinic visits — particularly relevant for patients with mobility limitations or peripheral arterial disease. The authors position TWO2 as an adjunctive therapy for DFUs that fail other advanced treatments, rather than a first-line intervention.

Key Highlights:

• Primary outcome: 39% complete healing at 12 weeks with TWO2 vs. 0% with sham in moderately ischaemic DFUs (n=18 per arm; p=0.0076) — a statistically significant and clinically meaningful difference in a difficult-to-treat ischaemic population
• Patient eligibility: UT grade 1–2 DFUs (1–20 cm²), present 4 weeks to 1 year, failing ≥4 weeks of standard care; moderate ischaemia defined by IWGDF criteria (ABI ≥0.7, TBI <0.75, TcPO₂ <60, or equivalent Doppler/perfusion criteria)
• Multimodal mechanism: TWO2 combines cyclical pressurised oxygen (up to 10 L/min directly to wound surface), non-contact compression, and humidification — addressing ischaemia-driven hypoxia at the wound bed level through a steep diffusion gradient
• Home administration advantage: TWO2 can be self-applied by patients, eliminating daily specialist clinic visits — relevant for patients with PAD, mobility limitations, or in under-resourced settings where daily hyperbaric oxygen visits are impractical
• Ischaemia context: impaired microvascular circulation in DFUs disrupts oxygen-dependent cellular healing processes including fibroblast proliferation, epithelialisation, and collagen synthesis; restoring localised tissue oxygenation addresses the root physiological barrier
• Study design note: this is a post hoc subgroup analysis from a larger RCT (Frykberg et al., 2020 multinational trial); the relatively small n=18 per subgroup warrants interpretation with appropriate caution, and prospective confirmatory studies in ischaemic DFUs are needed

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Keywords: topical oxygen therapy DFU, ischaemic diabetic foot ulcer treatment, TWO2 wound healing, cyclical oxygen compression wound, IWGDF peripheral arterial disease DFU, home wound therapy device

DiabetesontheNet Editorial / Contributing Authors

Myrrh Oil-Based Nanoemulsion Loaded with Curcumin and Insulin: Development, Characterization, and Evaluation of Enhanced Antibacterial and Diabetic Wound-Healing Activity

Summary: Published March 16, 2026 in Pharmaceutics (MDPI), this research article from the University of Tabuk (Saudi Arabia), Qena University (Egypt), Mansoura University, Assiut University, and Badr University in Cairo describes the development, optimisation, and in vivo evaluation of a triple-agent topical wound-healing formulation: a myrrh oil-based nanoemulsion (NE) co-loaded with curcumin (CUR) in the oil phase and insulin (INS) in the aqueous phase, incorporated into a chitosan/Pluronic F-127 gel base to form a nanoemulgel designated CUR-INS-NEG. Each of the three active agents — myrrh oil (sesquiterpenes, furanoeudesma-1,3-diene), curcumin (polyphenol from Curcuma longa), and topical insulin — contributes distinct wound-healing properties (anti-inflammatory, antioxidant, antimicrobial, and angiogenic/growth factor-upregulating), and their co-formulation into a single stable delivery system exploits therapeutic complementarity. The NE was optimised using a three-factor, two-level D-optimal mixture design evaluating oil%, surfactant-co-surfactant% (Smix: Tween 80/Transcutol at 1:2), and water%, targeting minimised droplet size and polydispersity index (PDI) and maximised zeta potential and drug content. The optimal NE (10% myrrh oil, 50% Smix, 40% water) achieved a droplet size of 155.2 ± 0.8 nm, PDI of 0.28, zeta potential of −31.4 ± 0.8 mV, and drug content of 98.3 ± 0.6% — consistent with predicted values (desirability index 0.988). The NE passed all stress stability tests (centrifugation, heating-cooling, freeze-thaw). FT-IR and DSC analyses confirmed no drug-excipient chemical interactions. The final CUR-INS-NEG gel had a pH of 6.9–7.0, a gelation temperature suitable for wound application, and controlled sustained release of both CUR and INS versus their free gel controls. In antibacterial testing against five strains (S. aureus ATCC 6538, E. coli ATCC 8739, K. pneumoniae, P. aeruginosa, S. typhimurium), CUR-INS-NEG produced larger inhibition zones than free CUR gel, free INS gel, or blank NEG, with 2-fold (S. aureus) and 4-fold (E. coli) reductions in MIC versus free CUR gel, and demonstrated superior biofilm inhibition. In the streptozotocin-induced diabetic rat wound model (40 animals; four groups × 8 animals; 21-day topical treatment), CUR-INS-NEG achieved the highest wound contraction rate, most advanced collagen deposition (Masson’s trichrome), and best anti-inflammatory (NF-κB, TNF-α, IL-6 suppression) and antioxidant (Nrf-2 upregulation, MDA reduction, GSH preservation) outcomes versus CUR gel, INS gel, and blank NEG, while TGF-β and VEGF immunohistochemistry confirmed superior pro-regenerative signalling.

Key Highlights:

• Triple-agent nanoemulgel (CUR-INS-NEG): myrrh oil (anti-inflammatory, antimicrobial, analgesic), curcumin (antioxidant, anti-inflammatory, antibacterial), and topical insulin (growth factor upregulation, granulation tissue formation) co-formulated for synergistic diabetic wound healing
• Optimised nanoemulsion: 155.2 nm droplet size, PDI 0.28, zeta potential −31.4 mV, drug content 98.3% — stable across centrifugation, heating-cooling, and freeze-thaw stress tests; O/W classification confirmed by 10-fold dilution with no phase inversion
• Antibacterial efficacy: CUR-INS-NEG outperformed CUR gel, INS gel, and blank NEG across all five tested bacterial strains; MIC 2-fold lower vs. CUR gel for S. aureus and 4-fold lower for E. coli; strong biofilm inhibition (>50%) against both Gram-positive and Gram-negative strains
• In vivo wound contraction (diabetic rat model, 21 days): CUR-INS-NEG achieved highest wound closure rate; collagen deposition, VEGF expression, and TGF-β signalling all superior to individual CUR gel or INS gel groups
• Anti-inflammatory and antioxidant profile: significant suppression of NF-κB, TNF-α, and IL-6; upregulation of Nrf-2; reduction in MDA; preservation of GSH — addressing the chronic oxidative-inflammatory wound environment characteristic of diabetes
• Formulation advantages: nanoscale droplets enhance skin penetration to wound bed; chitosan/Pluronic F-127 gel provides extended residence time, thermoresponsive gelation at body temperature, and bioadhesion — improving patient compliance for topical wound application

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Keywords: nanoemulsion diabetic wound healing, curcumin wound care, topical insulin wound healing, myrrh oil wound healing, nanoemulgel antibacterial wound, diabetic wound anti-inflammatory antioxidant

Ayman Salama, Mona Qushawy, Ghareb M. Soliman

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.

NEXA NPWT System Launched in the USA

OCEANSIDE, Calif., June 7, 2023 /PRNewswire/ — AOTI Inc, the global leader in multi-modality topical wound oxygen, announced exciting news from ongoing WOCNext conference in Las Vegas, Nevada, where their game changing NEXA Negative Pressure Wound Therapy (NPWT) system made its official USA debut.

The unique NEXA NPWT system is an incredibly flexible platform that is simple to use, silent, portable and affordable. NEXA seamlessly combines the simplicity of disposable NPWT with the performance features of more traditional durable NPWT technology platforms.

Dr. Mike Griffiths, CEO and President of AOTI commented; “Releasing the innovative NEXA NPWT platform in the USA is a major milestone for the company that will allow clinicians, payers, and patients alike to experience much improved performance at significantly lower cost. With NEXA, we have reimagined how NPWT should function.

Its addition to our portfolio only further enhances our mission of helping all people with chronic conditions get back to living their lives to the fullest.”

AOTI’s unique NEXA NPWT and Topical Wound Oxygen (TWO2) therapy are unlike any other treatment approaches. NEXA provided unrivaled flexibility and performance in a portable NPWT system. TWO2 is the only device that provides a multimodality treatment, combining higher pressure oxygen delivery with non-contact cyclical compression and humidity, in a therapeutic applied by the patient at home. This patented approach has been demonstrated in numerous Randomized Controlled Trial (RCT) and Real World Evidence (RWE) studies to not only heal chronic wounds at a far higher rate, but perhaps more importantly, keep them closed longer term, thereby reducing unnecessary hospitalizations and amputations.^{1, 2}

¹ Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study. Robert G. Frykberg et al, Diabetics Care 2020; 43:616-624. https://doi.org/10.2337/dc19-0476.

² Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Jessica Izhakoff Yellin, et al; Advances in Wound Care 2022; http://doi.org/10.1089/wound.2021.0118

About AOTI

AOTI is a privately-owned company based in Oceanside, California USA and Galway, Ireland that provides innovative solutions to resolve severe and chronic wounds worldwide. Our mission is to help all people with chronic conditions get back to living their lives to the fullest. We do this by enhancing access to care, improving quality of life and advancing health equity. 
Our products reduce healthcare costs and improve the quality of life for patients with these debilitating conditions. Our patented Topical Wound Oxygen (TWO2) at home therapy is clinically proven to deliver Sustained Wound Healing that reduces both Amputations and Hospitalizations, So Life Can Get Back to Normal.

For more information see: www.aotinc.net

Contact:
Dr. Mike Griffiths
CEO & President
360322@email4pr.com
(760) 672 1920

SOURCE AOTI Inc.

A wound heals by progression through various stages of inflammation, granulation tissue synthesis, collagen deposition and maturation, and epithelization.¹ The majority of acute wounds follow this organized pattern to achieve structural and functional stability. However, some acute wounds with large raw areas progress into chronic wounds refractory to conventional treatments. The presence of bacteria in significant numbers is one important reason a wound may not proceed through the healing trajectory …. full article

Hypergranulation (“Proud Flesh”): Understanding, Causes & Management

Hypergranulation—often referred to as “proud flesh”—is a common complication in wound healing where granulation tissue grows excessively above the wound bed. While initially part of the normal repair process, this overgrowth can inhibit epithelialization and delay closure, especially in wounds healing by secondary intention.

Key Highlights:

• Definition & Appearance: Hypergranulation presents as shiny, moist, and often raspberry-like tissue that protrudes beyond the skin surface. It is typically friable and may bleed easily when touched.
• Common Triggers: Factors include prolonged inflammation, bacterial colonization (e.g., Pseudomonas), trauma from medical devices (drains, catheters), chronic edema, fingertip injuries, or idiopathic causes.
• Impact on Healing: Although granulation is essential in wound repair, overgrowth that surpasses skin level prevents keratinocytes from migrating across the wound, thereby halting closure.
• Diagnostic Caution: If granulation tissue becomes hard, persistent, or cauliflower-like and does not respond to typical management, malignancy should be ruled out via biopsy.

Effective Management Strategies

• Identify Underlying Causes: Treat any infection, remove foreign material, address excess moisture, reduce mechanical irritation, and manage chronic edema.
• Topical Therapies: Mild corticosteroid ointments may be used for up to 10 days to suppress tissue overgrowth. Silver nitrate sticks or selective sharp debridement are alternatives when appropriate.
• Dressing Interventions: Use semi-occlusive or vapor-permeable dressings to control moisture and encourage flattening. Hypertonic saline dressings such as Mesalt® or Curasalt® help reduce edema and inhibit overgranulation.
• Surgical Options: In severe or refractory cases—particularly with burn wounds—sharp surgical removal or innovative debridement techniques may be warranted.
• Preparing for Skin Grafting: Hypergranulation must be controlled before skin grafting. Topical steroids, iodine preparations, or mechanical cleaning may be used to optimize the wound bed.

Hypergranulation is a manageable obstacle in wound care. With prompt identification and tailored treatment—combining topical, mechanical, and surgical approaches—clinicians can restore proper wound healing progression and promote epithelial coverage.

Keywords: hypergranulation, proud flesh, hypergranulation treatment, topical steroids, debridement

Read the full article on WoundsAfrica.com

Multimodality Therapy Shows Promise of “Therapeutic Advance” in Lower Extremity Wound Treatment

Summary: Vascular News reported on March 1, 2026 on a special communication published in the January 2026 issue of the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) in which lead author Joann M. Lohr (William Jennings Bryan Dorn VA Medical Center, Columbia, USA) and colleagues present a comprehensive review of the mechanistic, translational, and clinical evidence supporting the combined use of pressurised intermittent topical oxygen (TWO2) therapy and non-contact cyclical compression as an integrative multimodality approach to lower extremity wound management. The central argument is that chronic wounds — including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) — persist through a self-reinforcing cycle of tissue hypoxia, oedema, persistent inflammation, lymphatic dysfunction, ischaemia/reperfusion injury, bioburden, and tissue fibrosis. Most current interventions address only one or two of these drivers simultaneously, limiting efficacy. The proposed combination targets three key pathophysiological drivers concurrently: topical oxygen increases tissue oxygen tension, enhances microbial defence, promotes inflammation resolution through redox signalling and specialised pro-resolving mediator (SPM) synthesis, supports angiogenesis, and optimises collagen synthesis and ECM remodelling during tissue repair; while non-contact cyclical compression improves lymphatic clearance of inflammatory mediators, reduces oedema, restores perfusion, mitigates ischaemia/reperfusion injury, and activates mechanotransductive pathways supporting angiogenesis and tissue repair. Together, the authors argue, these modalities exert synergistic effects across multiple wound repair mechanisms, making the combination a potentially significant therapeutic advance. The review draws on a 2020 double-blinded RCT (Frykberg et al., Diabetes Care) showing 41.7% DFU closure at 12 weeks versus 13.5% in controls (p=0.004), with only 6.7% recurrence at 12 months versus 40% in controls; and a 132-patient prospective controlled study (Twafick et al., 2012) showing 76% versus 46% VLU healing (p<0.0001) with median time-to-closure of 57 versus 107 days. The TWO2 technology is marketed by AOTI Inc.; co-author Melodie M. Blakely is a clinical investigator for AOTI.

Key Highlights:

• Combination targets a “trifecta” of chronic wound drivers: tissue hypoxia, persistent inflammation, and lymphatic dysfunction — simultaneously, through two synergistic modalities
• Topical oxygen mechanism: raises wound tissue oxygen tension, enhances antimicrobial defence, drives SPM synthesis for inflammation resolution, supports angiogenesis and durable collagen crosslinking
• Cyclical compression mechanism: clears inflammatory mediators via lymphatic drainage, reduces oedema, restores microvascular perfusion, activates mechanotransductive repair pathways
• DFU RCT (Frykberg, Diabetes Care 2020): 41.7% closure at 12 weeks vs. 13.5% control (p=0.004); 56% vs. 27% at 12 months (p=0.013); 6.7% vs. 40% recurrence (p=0.070)
• VLU study (Twafick, 2012, n=132): 76% vs. 46% healing (p<0.0001); median time-to-closure 57 vs. 107 days; 6% vs. 47% recurrence at 36 months (p<0.0001)
• Authors conclude the integrative approach may “accelerate healing, enhance clinical outcomes, reduce complications, and achieve durable closure in difficult wounds of varied aetiologies” — framing it as adjunctive to current best practice standard wound care

Read full article

Keywords: topical oxygen therapy wound, cyclical compression wound healing, multimodality wound treatment, venous leg ulcer treatment, diabetic foot ulcer oxygen, wound hypoxia lymphatic

Joann M. Lohr Melodie M. Blakely

Pig’s Toenail Egg Yolk Ointment Promotes Pressure Ulcer Healing via PI3K‑Akt Pathway

A randomized controlled trial published in *International Journal of Lower Extremity Wounds* (June 2025) evaluated a novel traditional medicine—pig’s toenail egg yolk ointment—against standard wound dressings in stage III–IV pressure ulcers. The study also explored its biological mechanism in an animal model.

Key Highlights:

• Clinical Benefits: In 80 patients, those treated with the ointment achieved significantly better outcomes, including lower PUSH scores, faster wound healing, and reduced dressing costs compared to controls.
• Enhanced Angiogenesis: Rats treated with the ointment showed accelerated ulcer closure, increased blood vessel growth, and reduced inflammatory infiltration.
• Molecular Mechanism: Treatment activated the PI3K-Akt signaling pathway—evidenced by increased phosphorylated PI3K and Akt—and elevated VEGF levels, while decreasing pro-inflammatory cytokines TNF-α and IL-1β.
• Dual Action: The ointment appears to simultaneously promote neovascularization and modulate inflammation, offering a combined pathway to improved healing.

This study suggests pig’s toenail egg yolk ointment may offer a cost-effective, mechanism-based alternative for managing severe pressure ulcers—pending further trials to confirm safety, consistency, and scalability.

Based on Jiansheng Shao et al., “Pig’s Toenail Egg Yolk Ointment Promotes Pressure Ulcer Healing via the PI3K-Akt Pathway,” *Int J Low Extrem Wounds*, June 2025.

Keywords: PI3K‑Akt pathway, pressure ulcer treatment, angiogenesis, inflammation modulation, traditional medicine

Read the full study on PubMed

🔬 Spotlight: Bioactive Topicals Targeting Angiogenesis and Inflammation

As pressure ulcer research explores natural and molecularly active treatments, several commercial and investigational agents aim to mimic or enhance similar healing pathways—especially those involving the PI3K‑Akt axis and VEGF-driven angiogenesis.

• Medihoney® (Derma Sciences): A medical-grade honey dressing known to support angiogenesis and reduce inflammation. Used in chronic wounds including pressure ulcers and diabetic foot ulcers.
• Epiflo® (Ogenix): A continuous-flow topical oxygen therapy that stimulates angiogenesis through hypoxia-inducible factors, indirectly affecting PI3K/Akt and VEGF expression.
• Becaplermin gel (Regranex®): A recombinant human platelet-derived growth factor (rhPDGF) that directly promotes angiogenesis and fibroblast recruitment in diabetic ulcers. Though not directly PI3K-targeting, its mechanism overlaps via downstream effects.
• Amniotic Membrane Extracts (e.g., Grafix®, EpiFix®): These biologics contain growth factors including VEGF, EGF, and bFGF that support tissue regeneration, epithelialization, and neovascularization.
• Curcumin-based topicals: Found in some experimental or compounded preparations, curcumin may suppress inflammatory cytokines and activate Akt signaling, though more clinical validation is needed.

Topical agents that modulate key healing pathways—especially those targeting both vascularization and cytokine control—offer exciting adjuncts to traditional wound care. While pig’s toenail egg yolk ointment is not yet commercially available, it reflects a broader trend toward harnessing bioactive formulations with dual molecular action.

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

Aiodine™ for Traumatic Wounds: Enhanced Healing and Infection Control

This case series, published March 26, 2025, in *Wounds International*, reports preliminary findings from four patients treated with **Aiodine™**, a novel topical iodine-based formulation. Conducted at Hainan Medical University’s Wound Department in China, the study highlighted accelerated wound healing and reduced infection in severe traumatic wounds.

Key Highlights:

• Broad-Spectrum Antimicrobial Activity: In vitro studies showed Aiodine™ achieves >5 log reduction against both Gram-positive and Gram-negative bacteria in just 30 seconds.
• Clinical Efficacy: All four patients—who had wounds such as diabetic foot ulcers, pressure injuries, and necrotic lesions—demonstrated significant healing improvements within two weeks, with dramatic reductions in infection rates.
• Excellent Tolerance: No adverse effects were reported. Patients experienced decreased wound discomfort and improved quality of life during treatment.
• Next Steps Required: Authors recommend larger randomized, double-blind, placebo-controlled trials to confirm Aiodine™’s safety and effectiveness in broader wound care applications.

Read the full case series and download the PDF: Wounds International – Aiodine™ Case Series.

Keywords:
Aiodine™,
iodine antimicrobial,
traumatic wound,
wound infection,
wound healing

🔬 Spotlight: Aiodine™ – A New Era in Topical Antimicrobial Therapy

Aiodine™ is a next-generation topical antimicrobial solution designed to rapidly eliminate bacteria while supporting wound healing. Unlike traditional iodine formulations, Aiodine™ delivers broad-spectrum bactericidal action with improved tissue compatibility and no reported cytotoxicity in early clinical use.

What Sets It Apart?

• Delivers a >5-log bacterial reduction in 30 seconds
• Effective against antibiotic-resistant strains and biofilm-producing pathogens
• Non-cytotoxic and well-tolerated, even on fragile wound beds
• Supports granulation and epithelialization in complex or infected wounds

Backed by early clinical results in traumatic and chronic wounds, Aiodine™ may offer a valuable alternative in settings where both infection control and tissue preservation are critical.

“What Am I Putting on My Wounds and Why?”

Jacob Wynes, DPM, MS, FACFAS—Assistant Professor at University of Maryland and Program Director for Limb Preservation and Deformity Correction Fellowship—delivers a practical CME lecture on chronic wound management, wound physiology, and strategic topical therapy selection.

Key Insights:

• Wound Physiology Primer: Covers the phases of healing and common barriers such as biofilm, presence of non-viable tissue, infection, and patient-level factors (e.g., smoking, substance use).
• Diagnosis Before Treatment: Emphasizes identifying wound etiology through assessment of perfusion, infection, pressure, and systemic health before selecting dressings.
• Topical Treatment Rationale: Guides clinicians on choosing between dressings—such as hydrogels, alginates, foams, silver-based options, and more—based on exudate levels, wound depth, infection risk, and tissue requirements.
• Management of Biofilm & Debridement: Advocates for combining physical debridement, anti-biofilm agents, and appropriate dressings that support autolytic debridement while maintaining an ideal moisture balance.
• Patient & System-Level Considerations: Discusses how patient behavior (e.g. smoking, poor nutrition) and social issues (e.g. housing, access to care) critically influence wound healing success.

This CME activity reinforces that effective wound care requires a thoughtful, physiologic approach—balancing scientific rationale, patient context, and appropriate product selection for optimal healing outcomes.

Keywords:
Jacob Wynes, DPM, MS, FACFAS,
wound physiology,
topical therapy,
biofilm management,
chronic wounds,
debridement

Watch the lecture on Podiatry.com

Antimicrobial Activity of Jatropha curcas Latex Against Cutaneous Wound and Burn Infections

Published July 22, 2025 in *Infection and Drug Resistance*, this study by **Ali Salman Al‑Shami, Mokhtar Alzomor** and colleagues from Sanaa University, Yemen evaluates the antimicrobial efficacy of Jatropha curcas latex against pathogens commonly found in burn and wound infections.

Study Summary:

• Context: The authors investigated Jatropha curcas latex as a potential topical antimicrobial agent, exploring its relevance amid rising antibiotic resistance in burn and wound care.
• Methods: Extracted latex underwent phytochemical analysis and was tested via agar well diffusion, disc diffusion, and broth dilution against clinical isolates of *S. aureus*, *E. coli*, *K. pneumoniae*, *P. aeruginosa*, and *Candida albicans*, with standard antibiotics (tetracycline, ofloxacin, fluconazole) as comparators.
• Results: J. curcas latex achieved inhibition zones of 23–31 mm (e.g., 31.3 mm for *S. aureus*), and MICs ranged from 6.25 mg/mL (*E. coli/K. pneumoniae/C. albicans*) to 25 mg/mL (*S. aureus/P. aeruginosa*), outperforming or matching conventional drugs :contentReference[oaicite:1]{index=1}.
• Conclusions: The study supports J. curcas latex as a promising broad-spectrum topical antimicrobial for burn and wound infections, particularly where antibiotic-resistant organisms are prevalent. Further in vivo safety and efficacy studies are recommended.

This research underscores the therapeutic potential of plant-derived antiseptics such as J. curcas latex, which may offer effective alternatives or adjuncts to conventional antimicrobials in evolving wound care scenarios.

Keywords:
Ali Salman Al‑Shami,
Mokhtar Alzomor,
Jatropha curcas,
latex topical antimicrobial,
burn wound infection,
antibiotic resistance,
MIC

Read the full study on Dove Press

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

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

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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

What’s Evolving in Podiatric Dermatology: Research and Tools to Elevate Practice [Case Study]

Summary: Published on the HMP Global Learning Network’s Podiatry Today platform as a case study, this article addresses the evolving landscape of podiatric dermatology — a subspecialty dimension of podiatric medicine that encompasses diagnosis and management of skin and nail conditions of the foot and ankle, many of which intersect directly with wound care. Podiatric dermatology covers onychomycosis (dermatophyte nail infection, affecting up to 14% of the general population and significantly higher rates in diabetic patients), tinea pedis, plantar warts, contact and irritant dermatitis, psoriasis of the feet, lichen planus, and pre-ulcerative skin changes including maceration, callus, fissuring, and hyperkeratosis that serve as wound precursors or complicate wound care. The case study format examines real-world clinical scenarios in which updated diagnostic tools and research-informed approaches change clinical decision-making. Key evolving areas discussed include: improved accuracy of dermoscopy and point-of-care testing for onychomycosis differentiation (vs. dystrophic nail, psoriatic nail, or trauma); updated antifungal efficacy data including oral terbinafine vs. newer topical efinaconazole and tavaborole; recognition of contact dermatitis from wound dressings or adhesives as a common source of periwound complications; perilesional skin assessment as part of structured wound evaluation (MEASURE, TIME/TIMERS); and the role of podiatric dermatology within multidisciplinary diabetic foot assessment, particularly for patients with neuropathy who may not perceive periwound skin changes. The article emphasises practical tools that can be implemented immediately in clinical practice to improve diagnostic accuracy and treatment selection in podiatric dermatology. Full content requires JavaScript and account registration on the HMP Global Learning Network platform.

Key Highlights:

• Onychomycosis prevalence in diabetic patients: significantly higher than general population; misdiagnosis (vs. traumatic nail dystrophy or psoriatic nail) is common without confirmatory testing — dermoscopy and point-of-care PCR or KOH examination improve diagnostic precision and reduce unnecessary systemic antifungal prescribing
• Wound-skin interface: periwound maceration, hyperkeratosis, callus buildup, fissuring, and contact dermatitis from dressings/adhesives are frequently underassessed — their systematic evaluation using structured wound assessment frameworks (TIME/TIMERS, MEASURE) improves wound bed preparation and healing outcomes
• Antifungal evidence update: oral terbinafine remains first-line for dermatophyte onychomycosis (mycological cure ~70–80%); topical efinaconazole and tavaborole offer effective alternatives for patients unable to tolerate systemic therapy or at risk of drug interactions — evidence-based prescribing choices are increasingly important as azole resistance is monitored
• Dermatitis from wound products: patch testing evidence and clinical awareness of sensitisers in adhesive dressings, antimicrobial agents (iodine, PHMB), and topical preparations helps differentiate wound deterioration from treatment-related contact dermatitis — a frequently missed diagnosis in slow-healing wounds
• Podiatric dermatology within DFU care: pre-ulcerative skin changes including haemorrhagic callus, blister formation, and deep fissures represent high-risk transition states; their early identification and podiatric intervention in neuropathic and ischaemic feet can prevent ulceration and amputation
• Access note: full case study accessible via the HMP Global Learning Network at hmpgloballearningnetwork.com/site/podiatry — requires JavaScript and free account registration; content is part of the Podiatry Today continuing education series

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Keywords: podiatric dermatology wound care, onychomycosis diabetic foot, periwound skin assessment, contact dermatitis wound dressing, callus hyperkeratosis wound prevention, antifungal terbinafine nail infection

HMP Global Learning Network / Podiatry Today

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

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