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

AIM: 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. RESULTS: Twenty-one US sites enrolled and randomised 226 patients with hard-to-heal DFUs. The study was terminated early due to the COVID-19 pandemic, which led to a modified intent-to-treat (mITT) population of 207 patients, with 103 in the FBADM group and 104 in the SOC group. Of these participants, 161 completed the study per protocol (mPP population), with 79 receiving FBADM, and 82 without. At the first analysis point, patients treated with FBADM were found to be significantly more likely to achieve complete wound closure compared with SOC alone (mITT: 45.6% versus 27.9% p=0.008; mPP: 59.5% versus 35.6% p=0.002). The difference in outcome yielded an odds ratio of 2.2 (95% confidence interval (CI): 1.2, 3.9; p=0.008). Median time to closure within 12 weeks was 43 days for the FBADM group compared to 57 days for the SOC group (p=0.36). The median number of applications of FBADM to achieve closure was one. Adverse events were similar between groups and no product-related serious adverse events occurred. CONCLUSIONS: These results indicate that in many cases a single application of FBADM in conjunction with SOC offers a safe, faster and more effective treatment of DFUs than SOC alone.

A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers.

Randomized controlled clinical trials, the gold standard to determine treatment efficacy against control, have demonstrated advantages of skin substitutes for the treatment of chronic diabetic foot ulcers in comparison to standard of care. However, randomized controlled clinical trials comparing efficacy between two or more skin substitutes are very limited. With growing numbers of new skin substitutes, such studies are essential for treatment and policy-making decisions by wound care providers and payers. In this study, we analyzed clinical outcomes and product cost between a viable cryopreserved placental membrane (vCPM) and a human fibroblast-derived dermal substitute (hFDS) for the treatment of chronic diabetic foot ulcers in a prospective, multicenter, single-blind study. The outcomes of 62 patients were analyzed: 31 patients in the vCPM treatment group and 31 patients in the hFDS treatment group. Utilizing a non-inferiority trial design and the established treatment regimen of 8 applications for hFDS, we demonstrated that vCPM was not inferior to hFDS for the proportion of patients achieving complete wound closure (9.68, 90% CI: [10.67, 28.94]). However, preliminary findings show that vCPM may have better outcomes for wounds ≤ 5 cm2 : 81.3% (13/16) of wounds in the vCPM group vs. 37.5% (6/16) of wounds in the hFDS group reached complete closure at the end of treatment (p = 0.0118). A preliminary product cost analysis for wounds ≤ 5 cm2 may show significant savings for patients treated with vCPM. Average per-patient costs during the course of treatment were $3,846 and $7,968 (p < 0.0001) for vCPM and hFDS patients, respectively. These results may be used as guidance to wound care providers and payers.

Treatment of Hard-to-heal Diabetic Foot Ulcers With a Hepatic-derived Wound Matrix.

INTRODUCTION: Difficult-to-heal diabetic foot ulcers (DFUs) increase the likelihood of significant pathology and increased health care costs. OBJECTIVE: This study evaluates the ability of a novel hepatic-derived wound matrix (HD-WM) to treat hard-to-heal DFUs. MATERIALS AND METHODS: In total, 53 patients were enrolled and 38 completed per protocol. Patients had ulcers that had been present for at least 90 days and were non-responsive to at least 2 applications of an advanced biologic wound care product. Patients were treated with standard of care and offloading for a 2-week run-in phase. If they satisfied criteria, they were enrolled in the trial and treated with the HD-WM, and then seen weekly for assessment and additional treatment as needed. Patients continued weekly visits until the wound healed or went 12-weeks posttreatment without healing. RESULTS: Mean starting wound size was 3.5 cm2 and mean wound duration was 41.1 weeks. Median previous treatment applications of an advanced biologic were 3.0. Complete closure of the wound occurred in 22 of the 38 patients (57.9%) within the 12-week study period, while 16 of 38 (42.1%) of the wounds had failed to completely heal. The mean time to wound closure was 8.1 weeks; these patients received a median of 1 application of the HD-WM under investigation. Closure of the wound by 50% or greater at week 4 was highly predictive of complete wound closure by 12 weeks. Except for bodily pain (36-Item Short Form Health Survey), which significantly improved in patients whose wounds healed, quality of life measures did not show changes. CONCLUSIONS: The HD-WM under evaluation did well at closing difficult-to-heal wounds with minimal applications. These results are consistent with a previous study on this HD-WM.

Diabetes mellitus and the elderly: special considerations for foot ulcer prevention and care.

The risk of lower extremity amputation in persons with diabetes mellitus increases with advanced age, necessitating clinical vigilance. Individualized and comprehensive prevention efforts are required to address the complicated and diverse nature of the diabetic foot in the elderly patient, including promotion of lifestyle changes to offset diabetes, attention to cognitive deficits and economic limitations, and provision of foot care education and management (eg, emphasizing the need for appropriate foot wear). If an ulcer develops, physiologic and socioeconomic factors may influence its clinical presentation, assessment, diagnosis, and treatment. To help ulcer-related complications and prevent lower leg amputations, clinicians must address diabetes management; the cost of supplies; the importance of offloading, nutrition, and exercise; and challenges inherent to impaired eyesight, dexterity, and ability to self-care. A multidisciplinary approach is recommended. Additional research to enhance understanding of practice parameters in this population is needed to help clinicians manage the increasing numbers of older adults with diabetes mellitus.

Arthrodesis of the Charcot foot and ankle.

The unstable Charcot foot remains a challenge to even the most experienced surgeon. Reconstructive surgical management of the neuropathic Charcot foot is a valuable treatment option for the patient who has severe musculoskeletal deformity. Frequently, the unstable nature of this deformity prevents successful use of therapeutic shoes or braces. For these high-risk individuals, reconstructive surgery often is the only way to avoid amputation. With precise surgical technique, appropriate postoperative care, and meticulous patient compliance, stability can be restored to the dysfunctional foot. The management of the Charcot foot can be extremely rewarding for the patient and surgeon.

The effect of ankle equinus upon the diabetic foot.

The association between ankle equinus and common foot pathologies such as Achilles tendinitis, metatarsalgia, Morton's neuroma, hallux abductovalgus, and plantar fasciitis has been described. However, the association between ankle equinus and diabetic foot pathology has only been recognized recently. Over half of the non-traumatic amputations occurring in the United States are related to complications of diabetes. It is imperative that risk factors for lower extremity ulceration and amputation are identified and addressed. This article reviews the effect of ankle equinus deformity on the diabetic foot and the available treatment options. New data on the prevalence of equinus in a population of patients with diabetes are also presented.

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers.

OBJECTIVE: To compare healing rates at 12 weeks for full-thickness diabetic foot ulcers treated with OASIS Wound Matrix, an acellular wound care product, versus Regranex Gel. DESIGN: Randomized, prospective, controlled multicenter trial at 9 outpatient wound care clinics. SUBJECTS: A total of 73 patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol. INTERVENTION: Patients were randomized to receive either OASIS Wound Matrix (n = 37) or Regranex Gel (n = 36) and a secondary dressing. Wounds were cleansed and debrided, if needed, at a weekly clinic visit. Dressings were changed as needed. The maximum treatment period for each patient was 12 weeks. PRIMARY OUTCOME MEASURE: Incidence of healing in each group at 12 weeks. RESULTS: After 12 weeks of treatment, 18 (49%) OASIS-treated patients had complete wound closure compared with 10 (28%) Regranex-treated patients. CONCLUSION: Although the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior (P = .055), the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks.