A prospective, blinded, randomized controlled clinical trial evaluating the effect of the synthetic electrospun fiber matrix in the treatment of chronic diabetic foot ulcers

Abstract

The goal of this randomized, controlled, single-blind clinical trial was to compare the efficacy of synthetic electrospun fiber matrix (SEFM) with standard of care (SOC) in the treatment of diabetic foot ulcers (DFUs). Patients with DFUs ≤30 cm2 were randomized to receive either SEFM (RESTRATA®, Acera Surgical, Inc., St. Louis, MO) or SOC weekly for up to 12 weeks. SOC included foam or alginate dressing changes. The primary endpoint measure was the percentage of wounds achieving 100 % re-epithelialization at 12 weeks. Secondary endpoints included decrease in wound area, time to closure, and number of applications. Forty-six subjects were enrolled and randomized into two groups. In the per protocol (PP) population, 14/19 wounds (74 %) in the SEFM Group demonstrated 100 % re-epithelialization, compared with 6/18 wounds (33 %) in the SOC Group. The proportion of wounds closed and the persistence of wound closure in the SEFM Group was statistically superior to the SOC Group (90 % CI: 0.14, 0.62 / 0.12, 0.65) (Farrington-Manning) in the PP population. Time to complete healing in the SEFM Group (6.6 ± 3.0 weeks) was significantly reduced compared to the SOC Group (p = 0.046, 0.026) (Cox regression) in both the ITT and PP populations. This study represents the first randomized controlled trial to evaluate SEFM in the treatment of chronic DFUs and demonstrates superiority to SOC in achieving 100 % re-epithelialization within 12 weeks. Clinical trial registryNCT04918784.