Composite Skin Grafting with Human Acellular Dermal Matrix Scaffold for Treatment of Diabetic Foot Ulcers: A Randomized Controlled Trial

Abstract

BACKGROUND: Composite split-thickness skin grafting (STSG) with acellular dermal matrix (ADM) has been used successfully in burn injuries and trauma, but its use in treating diabetic foot ulcers (DFUs) has not been reported to date. This study investigated the efficacy and safety of composite STSG with ADM in the treatment of DFUs. STUDY DESIGN: Fifty-two patients with DFUs were randomized into experimental and control groups. Patients in the experimental group received composite STSG over ADM; the control group received STSG alone. The primary end point was recurrence rate 12 months after grafting. Secondary end points were the healing quality of the grafted site according to Manchester Scar Scale and complete wound closure and complication rates. RESULTS: The number of patients that experienced recurrence was significantly less in the experimental group compared with the control group (4.3% vs 22.7%; p = 0.02). The autografted sites of the experimental group had better appearance and lower Manchester Scar Scale scores (median 9 [interquartile range 8 to 10.25] vs median 11 [interquartile range 10 to 12]; p = 0.006). Rates of complete wound closure by weeks 2, 4, and 8 were similar, as were the rates of complications by post-grafting week 4 (38.5% vs 26.9%; p = 0.38). CONCLUSIONS: Composite STSG over an ADM scaffold provides an effective method to treat DFUs, with lower recurrence rates and better physical attributes compared with the traditional STSG method. Complete wound closure and complication rates were comparable between these methods.