Novel highly flexible collagen-loaded latex dressing to treat diabetic foot ulcer: A pilot clinical trial

Abstract

Diabetic Foot Ulcers (DFUs) are a common and severe complication of long-term, poorly managed type 2 diabetes. Among the 537 million people worldwide with type 2 diabetes, 19 % to 34 % are expected to develop a DFU in their lifetime. As life expectancy increases, so does the prevalence of DFUs, leading to complex and costly long-term care. This study introduces a novel, flexible dressing composed of natural rubber latex (NRL) infused with collagen (NRL-C), leveraging the natural healing properties of these biomaterials. The efficacy of NRL-C was validated through physicochemical characterization, in vitro and in vivo studies, and a pilot clinical trial. Results demonstrated that the NRL-C dressing promotes angiogenesis in endothelial cells, stimulates fibroblast and keratinocyte proliferation, accelerates wound closure, and exhibits biocompatibility in rodent models. Additionally, a pilot clinical study involving six diabetic patients revealed promising therapeutic outcomes, highlighting the potential of NRL-C as a cost-effective, safe, and sustainable strategy for DFU treatment.