Clinical Research

(CR-016) A Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Hybrid-Scale Fiber Matrix* in the Treatment of Chronic Diabetic Foot Ulcers

Co-Author(s):

Introduction: <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Chronic diabetic foot ulcers (DFUs) often experience inadequate healing rates, and alternatives to existing therapies are needed to improve the success of wound healing. Synthetic hybrid-scale fiber matrices promote wound closure with increased neovascularization and reduced inflammation compared to commercially available xenografts [1]. Pilot human clinical trials further demonstrated promising outcomes with 75-85% of DFUs treated with hybrid-scale fiber matrix achieving complete re-epithelialization by 12 weeks [1,2]. The goal of this randomized, controlled, single-blind clinical trial (NCT04918784) was to compare the clinical efficacy of hybrid-scale fiber matrix with standard of care (SOC) in the treatment of chronic DFUs. Methods: <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">atients with DFUs >4 weeks in duration and between 1-25 cm² were observed during a<span lang="NL" style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: NL; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> 2-week <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">run-in period before being randomized to receive either hybrid-scale fiber matrix or SOC applied weekly for up to 12 weeks. Post-application, ulcers were examined weekly for progression, percent area reduction, and quality of tissue healing. The primary outcome measure was the percentage of ulcers achieving complete re-epithelialization at 12 weeks. Results: <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Forty-eight subjects were enrolled and randomized to treatment with either hybrid-scale fiber matrix or <span lang="PT" style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: PT; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">SOC. After the<span lang="NL" style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: NL; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> 12 week<span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> treatment period, 14 of 19 ulcers (74%) in the hybrid-scale fiber matrix arm demonstrated complete re-epithelialization, compared with 6 of 18 ulcers (33%) in the SOC arm (p=0.014, p< 0.05). Ulcers that healed in the hybrid-scale fiber matrix arm had a mean time to complete closure of 6.6 <span dir="RTL" lang="AR-SA" style="font-size: 12.0pt; font-family: 'Times New Roman',serif; mso-ascii-font-family: Times; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Times; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">±<span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"> 2.9 weeks with a mean of 5.4 <span dir="RTL" lang="AR-SA" style="font-size: 12.0pt; font-family: 'Times New Roman',serif; mso-ascii-font-family: Times; mso-fareast-font-family: 'Arial Unicode MS'; mso-hansi-font-family: Times; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">± <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">2.8 applications. <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">The incidence of complete healing in the hybrid-scale fiber matrix arm is statistically superior to that in the SOC arm. Discussion: <span style="font-size: 12.0pt; font-family: 'Times',serif; mso-fareast-font-family: 'Arial Unicode MS'; mso-bidi-font-family: 'Times New Roman'; color: black; mso-color-alt: windowtext; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">The present study represents the first randomized controlled trial to evaluate the clinical efficacy of a synthetic skin substitute in the treatment of chronic DFUs and demonstrates the clinical superiority of hybrid-scale fiber matrix to SOC in achieving complete re-epithelization in refractory ulcers. The rate of complete healing as observed in this study is comparable to other advanced therapies. Trademarked Items: *Restrata® Acera Surgical, Inc., St. Louis, Missouri References: 1. Regulski MJ, MacEwan MR. Implantable nanomedical scaffold facilitates healing of chronic lower extremity wounds. Wounds. 2018 Aug;30(8):E77-E80.
2. Abicht BP, Deitrick GA, MacEwan MR, Jeng L. Evaluation of wound healing of diabetic foot ulcers in a prospective clinical trial using a synthetic hybrid-scale fiber matrix. FASTRAC. 2022 2(1):100135.