Terapia celular con membrana amniótica para la epitelización de úlceras complejas de pie diabético

Our objective was to determine the safety and efficacy of amniotic membrane (AM) treatment for epithelialization of complex diabetic foot ulcers, this tissue is obtained from healthy donors after scheduled caesarean section and negative serology for infectious diseases. Eighteen patients with diabetic macro and micro-angiopathy and foot deformations who presented diabetic foot ulcers with more than eight weeks of evolution were treated. The median age was 62 years. The Spanish Agency for Med-icines and Health Products (AEMPS) gave the authori-zation as compassionate use in all patients. The therapy was applied weekly on the wound bed. The mean treat-ment time before AM application was 24 and half months. The average area of the wounds was 10.56 cm2 (0.52 - 42.5). The mean time for epithelialization with AM was 5 months (1.5-13) with a mean of 11.22 applied membranes (4-40). No patient developed adverse events during treatment. Our results show that cryo-preserved human MA treatment is a safe and effective treatment in patients with complex diabetic foot ul-cers.