Safety evaluation of bi-layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers-SAFESKIN-DFU: A Phase 1 clinical trial.

ABSTRACT

AIM: To assess the safety and efficacy of a local skin substitute product in the treatment of chronic diabetic foot ulcers (DFUs). MATERIALS AND METHODS: Five patients were evaluated over 6 months. Skin substitutes were applied twice at 2-week intervals. Patients were monitored for any possible adverse effects and wound improvement. RESULTS: The results indicated the overall safety of the skin substitute, with only few adverse effects unrelated to this product. Significant reduction in wound size was observed in four patients during the initial 12-week treatment phase, with complete closure in two patients at 24 weeks. CONCLUSIONS: The application of a bi-layered allogeneic keratinocyte and fibroblast skin substitute in patients with chronic DFU was safe and associated with favourable wound healing results. Adherence to standard treatment protocols, including optimal offloading, is essential to maximize the likelihood of successful wound healing.