A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute.

UNLABELLED Background. It was hypothesized that the rate of wound closure and the number of grafts required will be the same when treating diabetic foot ulcers with TheraSkin®, a cryopreserved split-thickness skin allograft (SSA), as compared to Apligraft®, a bioengineered skin substitute (BSS). METHODS A prospective study using sequentially enrolled patients seen in a large podiatric practice encompassing multiple locations was conducted. Patients were sequentially enrolled and treated with either BSS or SSA. All other factors of treatment were standardized across the patient population. Data analysis included an analysis of co-factors in each group in order to determine if anything else may have influenced the outcomes. RESULTS Data from 17 wounds (16 patients) treated with BSS and 12 wounds treated with SSA were analyzed. The average wound sizes were comparable, as was the average number of applications utilized. These data revealed that 41.3% of the wounds treated with BSS closed within 12 weeks, as compared to 66.7% of the wounds treated with SSA. At 20 weeks, 47.1% of the wounds in the BSS group closed, while 66.7% of the SSA wounds closed. There were a comparable number of adverse events in each group, with none that were a direct result of the biologic material being used. CONCLUSION SSA resulted in a higher percentage of wounds closing after 12 and 20 weeks, as compared to wounds treated with BSS. There were no adverse events noted that were directly related to either graft material.