Clinical Evaluation of a Novel Synthetic Nanofiber Wound Matrix for the Treatment of Chronic Wounds.

Chronic wounds, including Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs) and Pressure Ulcers (PUs), present significant challenges for the patients, clinicians and healthcare systems. There remains a strong need for novel and effective technologies to accelerate the healing of these wounds. The objective of this prospective, single-arm pilot study was to evaluate the clinical performance of a novel nanofiber wound matrix for the treatment of chronic lower extremity wounds refractory to standard-of-care treatment at a single centre. A total of 15 patients with 15 chronic wounds (5 DFUs, 8 VLUs and 2 PUs) were included in this study. These wounds were non-healing to previous standard-of-care treatments for an average of 4 weeks. They were all treated with the novel nanofiber wound matrix with weekly clinical evaluation and re-application for a total duration of four (4) weeks, per the study protocol. The average wound area reduction (WAR) was 83.6% upon 4 weeks of treatment with the application of the subject wound matrix, as an adjunctive measure to the standard of care. Additionally, seven (7) of the 15 wounds (46.7%) completely healed starting from Week 3, and the average complete healing time was 13.9 days. These results demonstrated accelerated healing effects of the subject wound matrix, when compared to the standard of care reported in literature, where the average WAR was at 62.9% at Week 12, six (6) of the 18 wounds (33.3%) were completely healed within 12 weeks, and the average complete healing time was 49.0 days. These results demonstrated that the subject wound matrix is a safe and effective novel technology in treating chronic wounds, providing significant clinical and economic benefits for patients with various chronic wounds.