(CS-149) A Single Arm Pilot Study Evaluating Wound Closure with Application of a Unique Biodegradable Matrix in the Treatment of Non-healing Diabetic Foot Ulcers.
Co-Author(s):
David Armstrong, MD, DPM – Peri
Introduction: Diabetic Foot Ulcers (DFUs) are a major burden on healthcare systems and on patients. They require long-term care, multiple treatments, frequent visits, and there is a myriad of different treatment modalities, all varying in results and efficacy. The desired result is achieving and maintaining complete closure of the wound. To treat these complicated non-healing wounds, a bilayer biodegradable synthetic matrix (BBSM) has been created to serve as a foundation for new organized tissue formation and as a temporizing matrix. This study was designed to evaluate the efficacy of BBSM with the percent of patients achieving complete closure within 12 weeks.
Methods: We conducted an open-label prospective pilot study on 10 patients with DFUs. The indications for the application of BBSM were a present University of Texas Grade 1A/Wagner Grade 1 DFU labeled as the index ulcer. If more than one ulcer was present, only the largest was treated with BBSM. The ulcer had to be present and non-healing for more than 4 weeks and less than 1 year, and range in size from 1.0 cm2 to 25 cm2 . Adequate circulation to the affected foot was required, with a non-infected wound. The subject's diabetes had to be controlled by HgA1c measurements.
Results: All of the 10 patients remained as active participants of the study for its entire duration. Complete closure of the index ulcer was achieved in 7 out of 10 patients (70 percent) within 12 weeks or less. The mean time to closure was 6.25 weeks with the fastest healing at 2 weeks. All healed wounds remained closed upon study confirmation closure assessment visit 2 weeks later. While the remaining 3 patients did not achieve full closure of their index wound within 12 weeks, they did however show a significant reduction in wound size during the course of the treatment phase.
Discussion: This novel technology (BBSM) proved to be effective in the treatment of DFUs. The high rate of wound closure, ability to quickly achieve full closure, and ease of use make it an acceptable treatment modality for non-healing DFUs. Even though 3 of the 10 patients did not achieve full closure at the 12 week mark, the marked improvement was clinically significant. its temporizing ability facilitates the dressing change process and can potentially decrease the frequency of visits. Further studies with level-one evidence will confirm these initial findings. Additional studies may be performed to investigate recidivism rates post closure with BBSM.
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