Chronic non-healing ulcers are a significant medical problem and the incidence of these wounds is expected to increase as the United States population ages. It was projected that approximately 1,400,000 diabetics in this country alone would suffer from Diabetic foot ulcer (DFU) in 2015. The three major challenges in the medical management of DFU are 1) reduction of microbial infection both directly and through enhancement of a productive immune response, 2) restoration of a constructive wound healing microenvironment, and 3) induction of sufficient revascularization. A recent European study showed that approximately 28% of patients with infected DFU required amputations. Although the data are challenging to interpret due to the wide range of disease severities included in the analyses, standard therapies only cure approximately 30% of DFU after 20 weeks and at best advanced modality therapies achieve ~56% healing at 12 weeks. The increasing prevalence of chronic non-healing ulcers poses significant clinical challenges to wound care, often requiring the use of potent antibiotics with undesirable side effects on wound healing. However, no current product addresses both infection and closure of chronic non-healing ulcers. There is an unmet medical need for alternative products assessed by randomized, controlled trials with well-defined and controlled manufacturing processes for the treatment of chronic cutaneous ulcers. The present review emphasizes on development of the next generation of therapeutic skin substitutes which promote wound closure.
Ulcers, treatment, diabetic, biological skin substitute
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