(CR-077) Cellular vs. Acellular Matrices for the Treatment of Diabetic Foot Ulcers: A Randomized Clinical Trial

Ramanjot Kaur, MD – PGY-3 - Family Practice Resident; Catherine Tchanque-Fossuo, MD, MS – Dermatologist; Hadar Lev-Tov, MD, MS – Dermatologist; Kaitlyn West, MS; Pallas Lim, BSN; Nuen Yang, BS; Mirabel Dafinone, BS; Rawlings Lyle, BS; Chin-Shang Li, Ph.D.; David Rocke, Ph.D.; Sara Dahle, DPM, MPH; Rivkah Isseroff, MD

Introduction: The healing rates for chronic diabetic foot ulcers (DFU) are relatively low with the current standard of care (SOC), prompting the use of advanced wound care therapies. The purpose of the study was to determine whether a cellular matrix (CM) product resulted in better healing rates than acellular matrix (ACM) product, given associated differences in cost.

Methods: This was a federally-funded, non-industry, randomized, single-blinded, three-arm, controlled trial (cellular vs. acellular matrix to standard care) carried out in the VA Northern California Health Care System (ClinicalTrials.gov NCT01450943). Patients with a full thickness, nonhealing DFUs, who met inclusion/exclusion criteria were enrolled. After 2-week run-in period, patients were randomized to either SOC, or SOC + CM or SOC+ ACM arm. SOC included weekly sharp debridement and offloading; treatment groups had weekly SOC and either CM or ACM applied for up to 8 visits until the primary endpoint (12 weeks), after which only SOC was provided until the secondary endpoint (28 weeks).

Results: Of 169 eligible patients, 138 were enrolled and 117 randomized. For 12 weeks, patients received SOC, SOC + CM, or SOC + ACM. The primary outcome was the percentage of wounds healed by 12 weeks. Of the 117 subjects, 41 were in the CM group, 48 in the ACM group, and 28 in the SOC group. Complete re-epithelialization of the ulcer by 12 weeks occurred in 59% of the 117 total subjects: 49% in the CM group, 69% in the ACM, and 57% in the SOC group, however these outcomes were not significantly different, p >0.05). 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 (not statistically different Chi-square test, p=0.78). No differences were found in wound recidivism or adverse event occurrence between groups.

Discussion: CM are far more expensive than SOC or ACM, so CMs should be routinely used only if there is sufficient evidence of their improved healing performance relative to other modalities. In both primary and secondary outcomes in this trial, chi-square test among the three groups showed no significant difference. Minimizing using products that do not demonstrate evidence of improvement of healing of full thickness DFU’s can reduce the economic burden. Ultimately, improving SOC provides the best outcome for DFU treatment, but if selecting matrices, ACM appears to be more cost-effective approach for healing DFUs.