Use of a Novel Purified Reconstituted Bilayer Matrix for Treatment of Chronic Diabetic Foot Ulcers: A Retrospective Case Series

Abstract

Background. With the lifetime risk of DFU being 34% and the rate of chronic wounds increasing, there is a need for advanced therapies offering rapid, reliable, and safe healing. Materials and Methods. A retrospective review was performed of 10 cases in which a novel PRBM was used for treatment of chronic DFUs. Patients who presented with DFUs refractory to topical wound care and offloading for longer than 4 weeks received weekly application of PRBM for up to 12 weeks along with a standard treatment regimen at a single outpatient center. At weekly visits, the wound was measured, inspected for signs of complications, cleaned, and debrided as necessary, followed by PRBM application until complete epithelialization or for 12 applications. The primary outcome was complete wound closure at 12 weeks. Secondary outcomes included time to closure, DFU percent area reduction, and material cost to closure. Results. Mean wound healing time was 6.1 weeks, with 90% of wounds closed at 12 weeks. Six wounds were healed at 6 weeks, 2 at 7 weeks, and 1 at 12 weeks. One wound did not close over the study period. Mean wound area reduction was 85% at 6 weeks and 94% at 12 weeks. Patients tolerated PRBM application with no reported pain or discomfort. No adverse events were reported. Mean PRBM cost to closure for healed wounds was $2624. Conclusions. Treatment of chronic DFUs with PRBM is safe and efficient to achieve complete healing.