Safety evaluation of bi-layered allogenic keratinocyte and fibroblast skin substitute for diabetic foot ulcers-SAFESKIN-DFU: A Phase 1 clinical trial.
Shayan FarzanbakhshMohammad Reza AminiHoda MadaniBahareh SadriSeyedeh Nafiseh HassaniNasrin FallahAzam SamadianRaheleh AghdamiZahra KhalajasadiHossein BaharvandAbdolhossein ShahverdiEnsiyeh Hajizadeh-SaffarPublished in: Diabetes, obesity & metabolism (2024)
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.