Bioactive split thickness skin allograft appears to ‘significantly improve’ wound healing in diabetic foot ulcer

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.

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