Treating diabetic foot ulcers with bioactive split thickness skin allograft (BSA) can improve healing and reduce the rate of adverse events, a clinical trial has shown.
The American study set out to evaluate BSA in comparison to standard of care alone in the treatment of DFUs.
From a pool of 100 participants with non-healing DFUs, 50 were treated with a BSA while 50 were treated with standard of care (SOC, collagen alginate dressing) at 12 weeks. The care for participants in both groups included glucose monitoring, a weekly debridement where appropriate, and an offloading device.
The study, which was led by Charles Zelen, from the Professional Education and Research Institute in Virginia, reported: “The primary endpoint was proportion of full-thickness wounds healed at 12 weeks, with secondary endpoints including differences in percent area reduction (PAR) at 12 weeks, changes in Semmes-Weinstein monofilament score, VAS pain, and w-QoL.
“The result illustrated in the intent-to-treat analysis at 12 weeks showed that 76 per cent (38/50) of the BSA-treated DFUs healed compared with 36 per cent (18/50) treated with SOC alone (adjusted P = .00056). Mean PAR at 12 weeks was 77.8 per cent in the BSA group compared with 49.6 per cent in the SOC group (adjusted P = .0019).”
The team concluded that adding BSA to standard of care “appeared to significantly improve wound healing with a lower incidence of adverse events related to treatment” when compared with standard of care alone.
The findings have been published in the International Wound Journal.