Tag: diabetic foot ulcers

A novel macrophage-regulating new drug has shown promise in treating diabetic foot ulcers according to the latest issue of article ….

Accumulating scientific evidence has revealed that targeting macrophage phenotypes might be a potentially effective therapy in DFUs because hyperglycemia increases the ratio of proinflammatory M1 to pro-regenerative M2 macrophages. This study is the first international Phase 3 randomized clinical trial of an investigation drug able to regulate M1/M2 macrophage activities in the patients with diabetic foot ulcers (DFUs). The investigational compound has been given a research code: ON101 (trade name: Fespixon) has demonstrated the clinical superiority to the standard care (an absorbent dressing). The primary endpoint, complete healing, was found in 60.7% of the ON101 group and 35.1% of the comparison group during the treatment period (p=0.0001). Time to complete healing, the secondary endpoint, was faster in the ON101 group (p=0.002). The researchers have reported that “Topical application of ON101 with gauze … 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

A multi‐centre, single‐blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of DFUs

Diabetic foot ulcers (DFUs) represent one of the many complications of long-standing diabetes.1 Not only are these wounds expensive to treat, with a recent systematic review showing that the mean cost was over $31 000 in 2015,2, 3 but complications, especially infection, can require prolonged antibiotic administration, deep and extensive debridement, and lower extremity amputations when these measures fail. Even relatively shallow (UT1A, Wagner 1) DFUs that do not respond to standard of care (SOC) are at risk for amputation of the affected area.2-5 This risk increases for patients who have had prior DFUs or amputations. Any product, therefore, that can prevent infection or disrupt biofilm while promoting wound healing in a moist environment is worthy of further investigation … 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

Introduction to the work of IWGDF Guidelines

Every 20 seconds somewhere in the world someone loses a leg due to the complications of diabetes. After such amputations, over half of these people will die within 5 years. At this moment, millions of people with diabetes suffer from poorly healing foot ulcers, which usually develop as a result of several factors. Successfully managing these ulcers, or, even better, preventing them, depends on the close collaboration of various types of health professionals; they must integrate up-to-date care in their specialty into an effective multidisciplinary foot team. The key factors for optimal outcomes are that team members share common goals and follow evidence-based, comprehensive guidelines … read more

Diabetic foot ulceration: an avoidable complication

At present, more than 380 million people worldwide have diabetes. By 2035, this will rise to 592 million. Some 77% of these people live in low- and middle-income countries.1 In emerging countries, in particular, health-care services are often difficult to access, and finding suitable therapies for diabetes can be challenging. Inadequate treatment of diabetes leads to complications such as diabetic foot syndrome (DFS). For an individual with diabetes, the lifetime risk of developing foot ulcers is at least 15%.2 In western countries, DFS remains the most common reason for hospitalisation of patients with diabetes. In addition, DFS is the major cause of non-traumatic lower limb amputation. This supplement aims to improve understanding of DFS and to present essential aspects of prevention, diagnosis and treatment … read more

Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial

The purpose of this clinical trial was to evaluate the safety and efficacy of a fetal bovine acellular dermal matrix (FBADM) plus standard of care (SOC) for treating hard-to-heal diabetic foot ulcers (DFUs). METHOD: A prospective, multi-centre, randomised controlled trial was carried out. The study included a 2-week run-in period, a 12-week treatment phase and a 4-week follow-up phase. The primary endpoint was complete wound closure at 12 weeks … read more

Impact of repeated remote ischemic conditioning on diabetic foot ulcers: A proof-of-concept study

Patients with a diabetic foot ulcer (DFU) suffer disabilities and are at increased risk for lower extremity amputation. Current standard of care includes debridement, topical antibiotics, and weight off-loading—still resulting in low rates of healing. Previous small-scale research has indicated that repeated remote ischemic conditioning (rRIC) is a novel modality that delivers significantly higher DFU healing rates. This proof-of-concept study was performed to expand the research on the utility of rRIC as an adjunctive treatment in the healing of chronic DFUs. Forty subjects (41 wounds) received rRIC treatment three times weekly in addition to standard of care for 12 weeks. Subjects that did not heal in this time frame but had a significant reduction in wound size were eligible to continue for an 8-week extension period. By the end of the extension period, 31 of the 41 DFU wounds (75.6%) in this study were determined to be healed. This compares favourably to the 25–30% standard of care average healing rate … read more

THE COST OF DIABETIC FOOT ULCERS

The annual cost of diabetes is tremendously expensive; according to the American Diabetes Association, it was $245 billion in 2012.1 While nearly $70 billion of this figure was associated with reduced workforce productivity, the remaining $176 billion occurred as excess healthcare expenditures.1 These costs can, in turn, be divided into those associated with treatment of the disease itself, those associated with chronic complications of diabetes, and those native to O&P professional interests: foot ulcers … read more

2,000,000 TWO2 Treatments Milestone Reached as TWO2 Study Is Highlighted in Systemic Review of Topical Oxygen Therapies

“This is another enormous milestone for our company and a testament to the ease-of use and durable clinical efficacy of TWO2 therapy, as well as to the tenacity of our entire dedicated care team. AOTI is proud to have been able to help heal the Diabetic Foot Ulcers and Venous Leg Ulcers of so many high-risk patients safely at home. Effective homecare therapeutics, such as provided by TWO2, have become vital in maintaining continuity-of-care by caregivers for their patients, especially during the recent COVID-19 pandemic,” stated Dr. Mike Griffiths, CEO and Medical Director of AOTI … read more

Emerging Roles of Long Non-Coding RNAs in Diabetic Foot Ulcers

Diabetes mellitus is one of the most widespread metabolic diseases in the world, and diabetic foot ulcer (DFU), as one of its chronic complications, not only causes a large amount of physiological and psychological pain to patients but also places a tremendous burden on the entire economy and society. Despite significant advances in knowledge on the mechanism and in the treatment of DFU, clinical practice is still not satisfactory, and our understanding of its cellular and molecular pathogenesis is far from complete. Fortunately, progress in studying the roles of long non-coding RNAs (lncRNAs), which play important regulatory roles in the expression of genes at multiple levels, suggests that we can apply them in the early diagnosis and potential targeted intervention of DFU. In this review, we briefly summarize the current knowledge regarding the functional roles and potential mechanisms of reported lncRNAs in regulating DFU … read more

Sensing technology to prevent diabetic foot ulcers

Innovative in-sole sensors will alert diabetic patients during excessive or extended activities that could trigger foot ulcers in a new system being developed at the University of Southampton … The Load Monitoring and Intervention System (LOMIS) processes real-time data from three directional force sensors and detects physical activities over extended periods of time in a five-metric dimensional risk model … Live risk alerts are communicated to patients through a connected App to mitigate the risk and dangers of ulceration and amputation … read more

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

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound’s capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks) … read more

PolarityTE Announces Diabetic Foot Ulcer Trial Met Primary and Secondary Endpoint

PolarityTE, Inc. (Nasdaq: PTE) today announced preliminary topline data demonstrating that a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers with SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254) met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) at 12 weeks. 100 patients were evaluated across 13 sites with 50 patients receiving SkinTE plus SOC and 50 patients receiving SOC alone … continue

Smart Socks? How This Tech Startup Is Targeting a Common Medical Problem

When Ran Ma told her parents she was dropping out of her master’s program in business administration to work on a sock prototype for diabetic patients, their reaction wasn’t exactly encouraging … “My dad said, ‘We’re not going to talk until you figure out your life,’ ” says Ma. “I don’t think my parents understood what I was doing.” … continue

Wound care awareness

One in four families has a member with a chronic wound. For this reason, it is crucial for us as wound care experts to educate patients, caregivers and other health care providers about chronic wounds and advanced wound care treatment options … Nearly 7 million people in the U.S. are living with a chronic wound, and the number is expected to grow over the next decade. A chronic wound can be painful, dangerous and scary for patients and drastically affect people by diminishing their overall quality of life and potentially decreasing life expectancy if left untreated …They are also dangerous and damaging to our health care industry. The cost associated with chronic wounds is more than $50 billion annually, and this affects 14.5% of Medicare beneficiaries each year … continue

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

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.

 

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, persons with diabetes are 15 to 40 times more
likely to require lower-leg amputation compared to the general population. Approximately
85% of amputations are preceded by the development of a neuropathic foot
ulcer.

 

Following a lower-limb amputation, people with diabetes not only suffer the
clinical and psychological consequences of limb loss, but also have a five-year mortality
rate of 50%. This is a higher mortality rate than is seen in breast cancer in females,
prostate cancer in males or lymphoma … read more

SomaGenics Awarded Multi-Year Funding for Hepatitis Delta Virus Therapeutic Program

SANTA CRUZ, Calif., July 30, 2018 /PRNewswire/ — SomaGenics, Inc. announces the award of a three-year, $2.9 million NIH grant in support of its Hepatitis Delta Virus (HDV) therapeutic program under Principal Investigator and SomaGenics CEO Brian H. Johnston, Ph.D. This Phase II grant, from the NIH’s Small Business Innovation Research (SBIR) program, continues the development of SomaGenics’ novel RNA interference (RNAi)-based approach under a Phase I SBIR grant and will fund late-stage preclinical studies and preparations for clinical trials.

 

HDV infection, which requires concurrent or prior infection with the hepatitis B virus, results in the most severe form of viral hepatitis, and no HDV-specific therapy exists. Chronic HDV has a 20% mortality rate and its incidence is rising globally. The establishment of U.S.–based Hepatitis Delta Connect (hepconnect.org), a public outreach program, highlights recent efforts to increase patient and physician awareness about the pressing need for HDV screening and treatment.

 

SomaGenics’ HDV therapeutic is a novel treatment modality simultaneously targeting the virus at multiple stages of its life cycle using the Company’s proprietary synthetic short hairpin RNA (sshRNA®) technology. “Current clinical treatments suffer from multiple problems including limited efficacy, high relapse rate and toxicity,” according to Anne Dallas, Ph.D., Principal Scientist.

 

To date, the Company has demonstrated efficacy of its sshRNA® HDV therapeutic in cell culture models and will use the new NIH funding to support efficacy studies in animal models as well as to optimize the Company’s novel delivery platform. “Our combination, multi-target approach reduces the likelihood of treatment resistance and targets non-host entities, lowering the chance of toxicity. We are excited that SomaGenics’ therapeutic may have the potential to cure HDV patients,” explains Dr. Dallas.

 

Somagenics’ sshRNAs® are highly potent RNAi triggers, with IC50’s in the low picomolar range. sshRNAs® have distinct advantages over the more familiar siRNAs, including the fact that they consist of single chemical entities, simplifying their production and purification, and their lack of off-target effects from “passenger” strand retention. sshRNAs® are suitable for use in many indications in addition to HDV, with therapeutics currently in development for chronic wound healing including diabetic foot ulcers.

SomaGenics, Inc. is a privately held company with offices and laboratories located in Santa Cruz, California. The Company specializes in developing novel RNA-centered approaches to address unmet life science research and medical needs. Core competencies include RNA molecules as therapeutic agents, drug targets and biomarkers as well as the development of innovative kits for RNA analysis.

 

For information on SomaGenics’ HDV program or the sshRNA® platform, please contact Anne Scholz, VP Business Development, 831-426-7700 x20, 199087@email4pr.com

 

SOURCE SomaGenics, Inc.

Press Release from PRNewswire

Till We Get the Healing Done

It is estimated that in the United States alone, diabetes affects 29 million people. Patients who suffer from this illness are susceptible to chronic leg and foot ulcers. These diabetic wounds are particularly likely to lead to amputations, due to a disruption in the healing process caused by the illness. In this context, finding aids to artificially accelerate the healing process for diabetic wounds is crucial.

 

One presently used technique for accelerating the healing process, is the direct injection of stem cells into the wound. This has been shown to significantly increase the rate of wound healing. However, the injection protocol reduces the lifespan of the cells though mechanical damage. Once the cells have been injected, there is no cell matrix present, further limiting their viability … read more

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)

Smart Textiles Offer Development Opportunities In Medical

The medical field benefits from textile innovations, and the rapid development of sensor technology brings new products to the healthcare and wellness market.

 

The textile news has presented a number of stories centered in and around the medical industry in recent months. Whether the news relates to implantables and grafts, coatings and additives for wellness and bacteria protection, or innovative uniform fabrics, the textile industry is playing a role in medical progress. One particular area of note is sensor technology. Rapid development is taking place in the sensor market, and many companies are developing smart textile products for medical and health-related applications.

 

Making Socks Smart
Recently, San Francisco-based health technology company Siren introduced Neurofabric™, a Diabetic Sock and Foot Monitoring System that features microsensors embedded directly into the fabric. Six sensors — three across the ball of the foot, one in the arch and one on the heel — continuously monitor foot temperature looking for variation  … 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)

Therapy can accelerate wound healing

Using microcurrent therapy along with traditional wound care approaches significantly reduces wound size and lessens pain, according to a study in the Journal of Wound Care.

 

Harikrishna K.R. Nair, M.D., head of the wound care unit at Malaysia’s Hospital Kuala Lumpur, studied the effect of microcurrents on 100 chronic wound patients over four months in 2016. Their diagnoses included diabetic foot ulcers, venous leg ulcers and pressure ulcers … read more

Doctors who focus on the foot and brain team up on a smart insole

Professors David Armstrong and Charles Liu at first seemed to be an unlikely pair.

But the podiatric surgeon and neurosurgeon clicked on a personal level and promptly realized they had a lot to offer each other as Keck School of Medicine of USC collaborators.

 

Both were already studying how much information a person takes in through the nerves of the feet, how to preserve, repair or replace that information system, and how nerve damage can affect a patient’s mobility.

 

Armstrong is interested in metabolic health, mobility and neuropathy—the loss of nerve sensitivity that can occur in patients with diabetes, Liu noted.

 

“As a neurosurgeon, I’m interested in lower-extremity function and metabolic health, too,” he said. “In my work, I think about how to restore mobility to patients who can’t feel their legs. It’s a similar problem to diabetic foot ulcers.”

read more

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

Breakthrough Randomized Controlled Trial Demonstrating TWO2

     Efficacy in Healing Diabetic Foot Ulcers Unveiled at the American Diabetes Association 78th Scientific Sessions Conference

 

OCEANSIDE, Calif.June 26, 2018 /PRNewswire/ — AOTI Inc. announced today that initial results from its recently concluded Randomized Controlled Trial (RCT) demonstrating the efficacy of its patented multi-modality Topical Wound Oxygen (TWO2) homecare therapy in healing Diabetic Foot Ulcers were presented as a prestigious Late Breaking Abstract this weekend at the American Diabetes Association (ADA) 78th Scientific Sessions conference in Orlando, Florida.

 

The ADA estimates that Diabetes costs the USA$327 billion annually with a large portion of this cost related to treating comorbidities such as Diabetic Foot Ulcers (DFU)1. Non-healing DFU lead to increased mortality, morbidity & health economic burden as well as decreased QOL for the sufferers.

 

The study was conducted at seventeen Diabetic Foot Centers of Excellence spread across the USA and Europe, with a “who’s who” of expert Opinion Leaders as its investigators. The authors of the abstract highlighted the robustness of the study protocol that was of the highest scientific level ever seen in DFU studies, being not only conducted multi-center and multi-nationally, but being also double-blinded and placebo controlled. Additionally, the study protocol included the unprecedented step of a run-in of gold standard-of-care (SOC) for all subjects meeting enrollment eligibility criteria, ensuring that only those that truly failed to heal with SOC alone would be randomized into the active phase of the study.

full press release PR Newswire

 

Acellular Flowable Matrix in the Treatment of Tunneled or

     Cavity Ulcers in Diabetic Feet: A Preliminary Report

 

Campitiello, Ferdinando, MD; Mancone, Manfredi, PhD, MD; Della Corte, Angela, PhD, MD; Guerniero, Raffaella, MD; Canonico, Silvestro, MD

doi: 10.1097/01.ASW.0000531350.08738.34

 

OBJECTIVE: The authors aimed to explore the feasibility and safety of an advanced, acellular, flowable wound matrix (FWM) in patients with diabetes-related cavity or tunnel lesions involving deep structures.

 

METHODS: Patients with diabetic foot ulcers were hospitalized at the General and Geriatric Surgery Unit of the University of Campania in Naples, Italy, between March 2015 and December 2015. Twenty-three patients with tunneled or cavity ulcers were treated. The lesions were filled with the FWM. Surgical wound edges were either approximated with stitches or left to heal by secondary intention.

 

MAIN RESULTS: After 6 weeks, 78.26% of patients completely healed after a single application of the FWM. The healing time for all healed wounds was 30.85 ± 12.62 days, or 26.11 ± 5.43 days in patients for whom wound edges were approximated by stitches, and 57.66 ± 3.05 days in the patients who healed by secondary intention (P= .01). Permanent tissue regeneration was observed in a high percentage of patients, and shorter healing time was achieved. Study authors observed a low rate of complications such as major amputation and increased hospitalization.

 

CONCLUSIONS: The FWM seems ideal for tunneled and cavity ulcers with irregular geometry. This new porous matrix allows closure of the lesion while reducing healing time and demolition surgery … read more (purchase required)

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

Nearly 50% Reduction in Diabetic Foot Ulcers With Stem Cells

MUNICH — Local injection of mesenchymal stem cells derived from autologous bone marrow shows promise in healing recalcitrant neuropathic diabetic foot ulcers, a novel study from Egypt shows.

 

Presenting the results at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting, Ahmed Albehairy, MD, from Mansoura University, Egypt, said: “In patients who received the mesenchymal stem cells, ulcer reduction was found to be significantly higher compared with patients on conventional treatment after both 6 weeks and 12 weeks of follow-up. This is despite the fact that initial ulcer size was larger in the stem-cell–treated group.”

 

After 6 weeks, median ulcer reductions were 49.9% and 7.67% (= .001) in stem-cell–treated and control groups, respectively, and after 12 weeks, median ulcer reductions were 68.24% and 5.27% (= .0001). Complete healing was achieved in one case in the mesenchymal stem cell–treated group.

 

“The healing mechanism may be due to the pure effect of injected mesenchymal stem cells, which is due to the ability of these cells to simulate angiogenesis in the wound bed, decrease excessive inflammation, and suppress scarring,” explained Dr Albehairy … read more

Hemoglobin A1c Levels Not Tied to Wound Outcomes

HealthDay News — There does not appear to be a clinically meaningful association between baseline or prospective hemoglobin A1c (A1C) and wound healing in patients with diabetic foot ulcers (DFUs), according to a study published online April 16 in Diabetes Care.

 

Betiel K. Fesseha, MD, from Johns Hopkins University in Baltimore, and colleagues retrospectively evaluated the association between A1C and wound outcomes in 270 patients with 584 DFUs over a study period of 4.7 years… read more

 

 

Factors associated with amputation among patients

with diabetic foot ulcers in a Saudi population

 

Abstract

Objectives

A prospective study was conducted at the Armed Forces Hospital, Dhahran, Saudi Arabia, between January 2015 and December 2016 to identify the risk factors associated with amputation among diabetic foot ulcers DFUs patients.

Results

In total, 82 patients were recruited. Fifty-five of the patients were males (67.07%), the mean (SD) age of the participants was 60 (± 11.4) years, the mean duration of diabetes was 8.5 (± 3.7) years, and the mean haemoglobin A1c was 4.8 (± 2.8)%. In Univariate analysis, older age and high white blood cell count (WBC) were factors associated with amputation (OR = 1.1, 95% CI = 1–1.1, P = 0.012; and OR = 383, 95% CI = 7.9–18,665, P = 0.003, respectively). On the other hand, an ischaemic ulcer was half as likely as a neuropathic ulcer to lead to amputation (OR = 0.5, 95% CI = 0.3–0.9, P = 0.036), and a higher Wagner’s grade was found to be protective against amputation OR = 14.5, 95% CI = 4.3–49.4, P < 0.001. In conclusion, the current study showed that although a number of factors have been described to complicate diabetic ulcers by different researchers, none of those factors were identified in our study apart from older age and high WBC.

Introduction

Diabetes mellitus is a common endocrinopathy known for its various complications, including diabetic foot ulcers (DFUs) which often result in amputated limbs [1]. The prevalence of foot ulcers among patients with diabetes mellitus ranges from 4 to 10%, and its lifetime incidence may reach up to 25% [2]. Conservative management of DFU may be affected by proper offloading of the wounds, correct daily foot hygiene, and impaired distal vascular flow. Treatment of a DFU is difficult; it frequently gets infected, and it is therefore a very common cause of hospitalization [3]. Diabetes mellitus increases the risk of lower extremity amputations (LEAs) by up to 56% over 5 years, and … read more

Approval for commercialization of Heberprot-P® in Mexico

Havana, Cuba, May 4, 2018 – Heberprot-P® has been approved for commercialization in México. The Center for Genetic Engineering and Biotechnology (CIGB) is excited to announce regulatory approval of this innovative medicine indicated for advanced diabetic foot ulcer (DFU), which is expected to save thousands of people from lower limb amputation. The official approval date of Heberprot-P® was April 30th, 2018. Heberprot-P® stimulates granulation, accelerates DFU re-epithelization, and reduces healing time, surgical debridement, amputation risk, and recurrences. The intralesional infiltration of Heberprot-P® may be applied in combination with Good Wound Care (GWC), revascularization, and antibiotics. This medicine is an effective solution for an unmet medical need, a first in class product, unique worldwide, for DFU treatment. It is the only therapeutic choice available for advanced and complex DFU, reluctant to healing (grades 3, 4, and 5, according to Wagner’s classification).

 

Clinical experience derived from the intervention with Heberprot-P® in daily medical practice in Cuba was analyzed in 2013 in a study that reviewed the evolution of more than 2 000 patients as well as the pharmacovigilance of 1 788 patients, showing a 75% probability of granulation response, 61% healing rate, 71% amputation risk reduction, Bayes’ favorable factor (5.40), and complete granulation in 76% of ulcers in 5 weeks (Adv. Pharmacoepidem. 2013, 2 (2): 1000128; BMC Pharm. & Toxicol, 2013, 14: 44). The International Working Group of Diabetic Foot (IWGDF) evaluated results of the clinical trial performed with Heberprot-P® in Cuba and reported in 2009 as promising, highlighting the results obtained in only 2 weeks of treatment (Diabetes Metab Res Rev 2012; 28 (Suppl 1): 119-141).

 

In a later systematic review, clinical trials comparing the use of growth factors with GWC (Cochrane Database of Systematic Reviews 2015, Issue 10, Art. No. CD008548), the IWGDF’s evaluation was reported on all major issues and requirements of Heberprot-P® clinical trials in Cuba. Similar criteria were expressed by the IWGDF in the guidelines on DFU healing (IWGDF Guidance, 2015: 10). A fourth study reported similar observations on the intralesional EGF infiltration method: “… a highly significant difference between groups in the prevalence of granulation tissue after just 2 weeks” (Diabetes Metab Res Rev 2016; 32 (Suppl 1): 154- 168).

 

Results of clinical studies performed in Cuba, Russia, Turkey, Vietnam, Argentina, Mexico, and Ukraine were enough to demonstrate safety and efficacy profile of Heberprot-P®. This medicine has been used in more than 290 000 patients with diabetic foot ulcer (DFU) in Russia, Belarus, Georgia, Ukraine, Turkey, Algeria, China, Panama, Argentina, Cuba, Dominican Republic, Venezuela, Ecuador, Libya, Uruguay, Paraguay, Colombia, Guatemala, Philippines, Vietnam, Nicaragua, Saudi Arabia, Indonesia, Seychelles, Saint Lucia, Saint Vicente, Sri Lanka, Jordan, and Kuwait.

 

A national survey of health and nutrition in Mexico reported that prevalence of diabetes is 9.4% of total population, which sums up more than 11 million people, 9.1% of adult diabetic suffers DFU, and amputation is indicated to 5.5% of adult diabetics (National Survey of Health and Nutrition, INEGI 2016). According to recent reports, lower limb amputation is the unique alternative for 45% of diabetics with advanced DFU in Mexico (Diabet. Foot. Ankle. 2017 Sep 6, 8 (1): 1367210). In a previous study, similar results were reported: 42% patients with advanced DFU required major amputation (Wound Repair & Regen. 24 (5): 923-927).
Written by Jose A. Buxado, MSc., Assistant Researcher, CIGB.

 

The Center for Genetic Engineering and Biotechnology of Havana is an institution devoted to research, development, manufacturing, and commercialization of products and technology derived from life science.

 

Alyane Vazquez González, BA., Communication & Media, e-mail: alyane.vazquez@cigb.edu.cu. Ave 31 e/ 158 y 190, Playa, P.O. Box 6162, Habana 10600, Cuba.

 

This release was published on openPR.

High School Senior Awarded Scholarship for Creating an Orthotic

that detects and prevents diabetic foot ulcers.

 

Western Albemarle high school senior Meg Richey is awarded a scholarship at the 18th annual Emily Couric Leadership Forum at the Omni Charlottesville Hotel on Wednesday. Richey, who will attend Stanford University, was awarded a scholarship of $30,000 for her work creating an orthotic that detects and prevents diabetic foot ulcers.

Meg Richey was this year’s main award winner, and she received a $30,000 scholarship.

 

A senior at Western Albemarle High School who plans to study computer science at Stanford University, Richey has a provisional patent for a medical device and is the youngest person to study at the University of Virginia’s Biomedical Engineering Design Lab.

 

Her device, named after her childhood bus driver, Mike Morris, was envisioned after Morris died after developing a diabetic foot ulcer.

 

“He was the first and last person we saw during the day,” Richey said. “It was so important, especially in middle school, to feel like someone genuinely cared.”

 

The Morris Orthotic is a custom foot insole with sensors that detect changes in pressure at the bottom of a diabetic patient’s foot. Possibly the first custom-fit orthotic with sensor technology, it might alert a patient to life-threatening conditions that are hard to detect … 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 EColi, 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

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

To evaluate the efficacy of an acellular Flowable matrix

in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

 

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization … read more

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

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

Reduction of 50% in Diabetic Foot Ulcers With Stem Cells

MUNICH — Local injection of mesenchymal stem cells derived from autologous bone marrow shows promise in healing recalcitrant neuropathic diabetic foot ulcers, a novel study from Egypt shows.

 

Presenting the results at the European Association for the Study of Diabetes (EASD) 2016 Annual Meeting, Ahmed Albehairy, MD, from Mansoura University, Egypt, said: “In patients who received the mesenchymal stem cells, ulcer reduction was found to be significantly higher compared with patients on conventional treatment after both 6 weeks and 12 weeks of follow-up. This is despite the fact that initial ulcer size was larger in the stem-cell–treated group.”

 

After 6 weeks, median ulcer reductions were 49.9% and 7.67% (P = .001) in stem-cell–treated and control groups, respectively, and after 12 weeks, median ulcer reductions were 68.24% and 5.27% (P = .0001). Complete healing was achieved in one case in the mesenchymal stem cell–treated group.

 

“The healing mechanism may be due to the pure effect of injected mesenchymal stem cells, which is due to the ability of these cells to simulate angiogenesis in the wound bed, decrease excessive inflammation, and suppress scarring,” explained Dr Albehairy … 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

 

 

Prevention of hospital-acquired foot pressure injuries

Assessment and consideration of foot risk factors is essential for proactive prevention of hospital-acquired foot pressure injuries

 

The research outlined in this article aimed to see if high-risk feet were also identified as ‘at risk of ulceration’ by the Braden Score. One-hundred-and-thirty-two patients had foot risk stratified by a podiatrist and their admission Braden pressure injury (PI) risk level was compared. Only 36% were decreed to be at the same level of risk by both methods. The lack of agreement was demonstrated by a very low Kappa score. The Braden score underestimated PI risk to feet for 52% of the study population. Therefore, the authors concluded that less reliance on the Braden score is needed for the implementation of prevention to reduce rates hospital-acquired foot PIs … read more

Amit Jain’s Triple Assessment of Foot in Diabetes

A rapid screening tool

Diabetic foot is on the increase with prevalence rates of diabetes growing around the world. In spite of this, it is frequently a neglected entity in many countries. Screening of the diabetic foot serves to identify any underlying problem and helps one to immediately institute preventive and therapeutic measures. There are few screening tools currently used for diabetic foot. Amit Jain’s Triple Assessment of Diabetic Foot is a new, fast and easy screening tool from the Indian subcontinent that addresses the classic triad of the diabetic foot (neuropathy, ischemia, and infection) both specifically and effectively … read more

A Journey of a Thousand Steps to #ActAgainstAmputation

Diabetes is the sixth leading cause of death in North America. By 2020, an estimated 4.2 million Canadians will be living with the disease and its devastating complications. People with diabetes have an increased risk of developing diabetic foot ulcers (DFUs) as a result of the loss of protective sensation in their extremities. Twenty five percent of individuals with diabetes will have a DFU in their lifetime, increasing their risk of amputation and pushing their five-year mortality rate to surpass that of patients with Hodgkin’s disease, breast cancer or prostate cancer.1,2,3 The direct cost of diabetes in Canada now accounts for about 3.5% of public health-care spending, and this figure continues to rise.4 The cost of DFUs is an enormous strain on health-care systems: about $12.2 billion in 2010. Care for people living with diabetic foot ulcers needs to be holistic and requires addressing all factors that contribute to ulceration, including repeated trauma and pressure. For years, the Canadian wound-care community recognized and understood the importance and value of pressure … read more (pdf)

Stratatech Begins Test of Engineered Skin for Diabetic Foot Ulcers

Stratatech is moving forward with tests of a genetically engineered human skin that could heal the sores and wounds many diabetic patients get on their feet.

 

Madison, WI-based Stratatech, a subsidiary of U.K.-based Mallinckrodt (NYSE: MNK), said Wednesday that it had enrolled the first patient in a study of the skin tissue, called ExpressGraft-C9T1.

 

Stratatech said the ExpressGraft skin tissue builds on some of the same technologies the company pioneered in developing StrataGraft, its flagship skin replacement product. StrataGraft is cell-based skin tissue designed to coax the bodies of burn patients into regenerating skin … 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

Should Patients Buy Offloading Footwear From You?

It is a challenging, common situation: wound care patients require offloading devices for diabetic and/or neuropathic plantar ulcers, but there is no insurance coverage for those items.  You explain that they will bear the cost of the product(s), but they believe the expenses should be covered by you. When you offer to sell the product(s) directly or suggest the patients purchase them elsewhere, they refuse. Ultimately, their wounds worsen or don’t improve.

 

It is well documented that shoe-based offloading approaches are used more frequently than any other modality in the treatment of plantar diabetic foot ulcers (DFUs).1,2 It is equally well established that supporting data are limited.3 Additionally, since there is no reimbursement for shoe-based offloading, the products and materials that physicians select to create offloading structures may be based as much on acquisition cost and availability than on any empirical review. When a DFU is the sole indication, the only offloading options that are routinely covered by Medicare (or insurance) are total contact casting and Crow walkers, both of which are used infrequently and are not “accepted” by many physicians or patients.1,2 The result of this disconnect between modalities that are reimbursed versus approaches that most physicians use is that there is no broadly recognized standard of care and actual care is highly variable from facility to facility …
read more