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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Advances in Dermoepidermal Skin Substitutes for Diabetic Foot Ulcers
Francisco Javier Álvaro-Afonso1, Yolanda García-Álvarez1, Jose Luis Lázaro-Martínez1
1Diabetic Foot Unit, University Podiatric Clinic, Edificio Facultad de Medicina, Complutense University of Madrid, Instituto de Investigacion Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Abstract:
Diabetic foot ulcers (DFUs) are one of the major complications of diabetes, representing a leading cause of hospitalisation and non-traumatic lower limb amputations. Multidisciplinary management, patient education, glucose control, debridement, off-loading, infection control, and adequate perfusion are the mainstays of standard care. Despite all these, at least 30% of DFUs fail to heal within 20 weeks. Therefore, dermoepidermal skin substitutes (DSS) have been used as a new therapeutic adjunct for DFUs. This brief review outlines the recent advances in DSS for the treatment of DFUs. PubMed and Cochrane databases were systematically searched in May to July 2018 for systematic reviews published after 2013 and for randomised controlled trials (RCTs). A retrospective evaluation of 28 RCTs was performed. Rates of complete wound closure and time to healing were examined for 17 commonly available DSS. Healing rates after 12 weeks and time to complete closure in DFUs are heterogeneous among the 28 RCT. The best healing rates at 12 weeks were accomplished with dermal cellular substitutes (Epifix®, 100% and Amnioband®, 85%) and with dermal acellular substitutes (Allopatch®, 80% and Hyalograft®, 78.8%). Based on these studies, DSS used in conjunction with standard care appear to improve the healing rates of DFUs, as compared with standard care alone. Nonetheless, new studies with more homogeneous samples are needed to ascertain the role of ulcer size, duration, depth and/or type in the efficacy of DSS. Moreover, future RCTs should include patients with severe comorbidities, in order to be more representative of clinical reality.
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