Cellular Versus Acellular Matrix Products for Diabetic Foot Ulcer Treatment: The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE)— A Randomized Clinical Trial

Abstract

To determine whether cellular matrix (CM) products result in better healing rates than acellular matrix (ACM) products for nonhealing diabetic foot ulcers. RESEARCH DESIGN AND METHODS The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE) was a randomized, single-blinded, three-arm controlled trial. Patients (aged $18 years) with a full-thickness nonhealing diabetic foot ulcer who met inclusion/exclusion criteria were enrolled. RESULTS Of 169 eligible patients, 138 were enrolled and 117 randomly assigned. For 12 weeks, patients received standard of care (SOC), CM, or ACM. The primary outcome was the percentage of wounds healed by 12 weeks. Of the 117 participants, 41 were in the CM group, 48 in the ACM group, and 28 in the SOC group. There were 21 withdrawals, but seven had reached the first primary end point. Complete re-epithelialization of the ulcer by 12 weeks occurred in 59% of the 117 total participants: 49% in the CM group, 69% in the ACM group, and 57% in the SOC group (P = 0.16 by v2 test). At 28 weeks, 25 participants (61%) in the CM group, 27 (56%) in the ACM group, and 18 (64%) in the SOC group had healed (P = 0.78). No differences were found in wound recidivism or adverse event occurrence between groups. CONCLUSIONS No difference in efficacy was found between SOC, ACM, and CM, suggesting that SOC can reduce the economic burden of diabetic foot ulcer treatment.