Evaluation of wound healing of diabetic foot ulcers in a prospective clinical trial using a synthetic hybrid-scale fiber matrix

Abstract

Objective: Chronic diabetic foot ulcers (DFUs) often experience inadequate healing rates, and alternatives to existing therapies are needed to improve the success of wound healing. The objective of this clinical study (clinicaltrials.gov number NCT03312595) was to evaluate outcomes using a synthetic hybrid-scale fiber matrix for the treatment of DFUs. Methods: In this prospective multi-center clinical study, chronic DFUs were treated with the synthetic matrix. Post-application, wounds were examined weekly for wound progression and tissue healing for up to 12 weeks. Results: Twenty-four patients with DFUs completed the study and were included in the analysis. At the end of the 12-week treatment period, 18 of 24 wounds (75%) reported complete wound closure. The average reduction in wound surface area over 12 weeks was 96% ± 10%. For the wounds that healed, the average time to complete wound closure was 6.4 ± 2.5 weeks. The synthetic matrix resulted in significant healing of chronic non-healing DFUs unresponsive to at least one previous advanced wound care modality. The incidence of complete healing in the present study was observed to be notably greater than standard care methods and comparable to other advanced wound therapies. Conclusions: The findings suggest that the hybrid-scale fiber matrix may be a viable alternative to existing wound care modalities for the treatment of chronic DFUs. Level of Evidence: Level II

Keywords

• Chronic wounds
• Diabetic foot ulcers
• Extracellular matrix
• Prospective clinical trial
• Synthetic hybrid-scale fiber matrix
• Wound healing