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 Patients with diabetic foot ulcers(DFUs), in particular when unresponsive to standard wound care, face serious risks of severe complications, including infection and amputation. PRBM is an advanced acellular bilayer scaffold derived from two distinct porcine tissue sources2. The bilayer is designed with a highly porous layer that is applied in direct contact with the wound bed and a second compact outer layer that is mechanically robust. 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 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 one wounds were first pre-screened for a 2-week period. Patients who did not heal during pre-screening were randomized to receive a weekly application of either PRBM or SOC. The wounds were evaluated, measured, photographed and grafted if necessary at each visit 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. ResultsA total of 46 patients were pre-screened and signed consent. After the run-in period, 40 eligible patients were randomized to receive PRBM or SOC treatment. 39patients 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=20in the SOC group. 37 patients completed the study per protocol(PP), with 17receiving PRBM and 20 receiving SOC treatment. Wounds treated with PRBM were significantly more likely to heal within 12weeks than those receiving SOC(ITT—85% vs 30%,p=0.00043, PP 94%vs30% 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%vs9.8%) at 12weeks. The mean PRBM cost of healing was $1731. No product-related adverse events or wound complications have been observed.

Conclusion The results demonstrated that the use of PRBM was safe and effective for treatment of chronic DFUs. It significantly accelerated healing at a reasonable cost.