References
Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial
Abstract
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.
Diabetic foot ulceration (DFU) is a major health and economic problem that significantly impacts both patients and the healthcare system. According to the 2020 National Diabetes Statistics Report, 34.2 million Americans have diabetes.1 Estimates suggest that as many as 15% of patients with diabetes may develop a DFU in their lifetime.2,3 Concomitant conditions associated with diabetes, such as peripheral vascular disease, neuropathy and poor blood glucose control, contribute to the slow healing rates and high rates of recurrence of these wounds.4,5,6,7 An estimated 40% of patients with DFUs experience a recurrence within 1 year and 65% within 5 years, with 15% of patients undergoing an amputation during a 10-year follow-up period.8 The 5-year mortality rate for patients who undergo lower extremity amputation due to a DFU remains alarmingly high at 56%.6,7,9,10
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