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

Objective: To determine whether cellular matrix products result in better healing rates than acellular matrix products for non-healing diabetic foot ulcers.

Research Design and Methods: 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 randomized. For 12 weeks, patients received standard care, cellular matrix, or acellular matrix. The primary outcome was the percentage of wounds healed by 12 weeks. Of the 117 subjects, 41 were in the cellular matrix group, 48 in the acellular matrix group, and 28 in the standard care group. There were 21 withdrawals, but 7 had reached the first primary endpoint. Complete re-epithelialization of the ulcer by 12 weeks occurred in 59% of the 117 total subjects: 49% in the cellular matrix group, 69% in the acellular matrix group, and 57% in the standard of care group (Chi-square test, p = 0.16). At 28 weeks, the percentages were 25 (61%) in the CM group, 27 (56%) in the ACM group, and 18 (64%) in the SOC group 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 standard of care, acellular matrix, and cellular matrix, suggesting that standard of care can reduce the economic burden of diabetic foot ulcer treatment.