Use of a Purified Reconstituted Bilayer Matrix in the Management of Chronic Diabetic Foot Ulcers Improves Patient Outcomes vs Standard of Care – Results of a Prospective Randomized Controlled Multi-Center Clinical Trial

Introduction In a previous series of 10 patients the authors evaluated a unique Purified Reconstituted Bilayer Matrix(PRBM) and found the material safe and efficacious in the treatment of chronic DFUs1. PRBM is an advanced acellular bilayer scaffold derived from two distinct porcine tissue sources2. Its chemical composition is designed to bind and preserve growth factors and guide re-epithelialization by mimicking the structure of the basement membrane3 Methods To further evaluate the efficacy and safety of PRBM compared to standard of care(SOC) in treating non-healing DFUs the authors initiated an IRB-approved 40-patient prospective randomized controlled multicenter clinical trial. Patients with Wagner grade 1 wounds were first pre-screened for a 2-week period in which all patients receive a collagen-alginate(Fibracol) as part of a standard of care protocol.  Patients who did not heal during pre-screening were randomized to receive a weekly application of either PRBM or SOC. Wounds were grafted if necessary each week for up to 12 weeks. The primary study endpoint was complete wound closure at 12 weeks. Secondary endpoints included time to heal, percent area reduction, product wastage and cost to closure. Results A total of 46 eligible patients were pre-screened and signed consent. Six patients were no longer eligible after 2–week run in period, and 40 patients were randomized to PRBM or SOC treatment. 39 patients had completed treatment and evaluation. In the intent to-treat(ITT) analysis, all 40participants were included, with n=20 in the PRBM group and n = 20 in the SOC group. 37 patients completed the study per protocol (PP), with 17 receiving PRBM and 20 receiving SOC treatment. Wounds treated with PRBM were significantly more likely to heal within 12 weeks than those receiving SOC(ITT—85% vs 30%, p=0.00043, PP 94% vs 30% p=0.000075). They also healed significantly faster (mean 36.8 days vs 66.5 days SOC, p=0.002) and achieved a greater wound area reduction(mean 96.4% vs 9.8%) at 12 weeks. The mean PRBM cost of healing was $1731. No product-related adverse events have been observed. Conclusion Use of PRBM was safe and effective for treatment of chronic DFUs. It significantly accelerated healing at a reasonable cost.