A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers.

INTRODUCTION: Venous leg ulcers (VLUs) are often chronic and difficult to treat, which makes alternative options to conventional care necessary to improve ulcer healing rates. While human acellular dermal matrices (ADMs) have shown promise in treating diabetic foot ulcers, no comparative studies have been published regarding VLU treatment. Decellularized ADMs (D-ADMs) have been used successfully in the treatment of a wide variety of wound repairs and may be effective in treating VLUs.

OBJECTIVE: This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of D-ADM compared with conventional wound care management in patients with chronic ulcers of the lower extremity.

MATERIALS AND METHODS: Patients were randomly assigned to receive either D-ADM or standard of care (control) in a 2:1 ratio. Treatment began at week 0 and wounds were evaluated on a weekly basis until wound closure was observed or the patient completed 24 weekly follow-up visits.

RESULTS: Eighteen patients were included in the D-ADM arm and 10 patients in the control arm. There was a strong trend of reduction in percent wound area for D-ADM patients with an average reduction of 59.6% at 24 weeks versus 8.1% at 24 weeks for control patients. In addition, healed ulcers in the D-ADM arm remained closed at a substantially higher rate after termination than healed ulcers in the control.

CONCLUSIONS: In this report, the authors note the successful increase in healing rates and rate of percent wound closure as compared with conventional care options.