Effect of Electrospun Poly (L-lactide-co-caprolactone) and Formulated Porcine Fibrinogen for Diabetic Foot Ulcers

OBJECTIVE To compare the effect of topical application PLCL/Fg dressing with alginate dressing (ConvaTec Ltd) when treating DFUs. DESIGN, SETTING, AND PARTICIPANTS A single-center, prospective, randomized, patient-blinded clinical trial was conducted from February 1, 2023, to November 16, 2023. The eligible patients with DFUs of 1 to 20 cm2 present for at least 1 month and with Wagner grade 1 or 2. They were randomized 1:1 to receive PLCL/Fg or control alginate dressing. In PLCL/Fg group, 10 wounds samples were got from five patients at the time of the first dressing application and 50% wound healing time point. The wound specimens were subjected to messenger RNA sequencing. INTERVENTIONS Participants received PLCL/Fg dressing 1 to 3 times per week or Alginate dressing 3 times per week for 12 weeks. MAIN OUTCOMES AND MEASURES Primary end point was the incidence of complete healing. Complete healing was defined as complete re-epithelialization of the ulcer bed and absence of secretion. Secondary end points were time to relevant 50% wound reduction, infection, treatment-associated adverse events, and the microenvironment changing during wound healing.