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

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, lead...

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Autores: de Barros, Natan Roberto [UNESP], Chagas, Ana Laura Destro [UNESP], Forster, Samuel, Sant'Ana Pegorin Brasil, Giovana [UNESP], Ribeiro, Geraldo Monteiro, Olivato, Orestes Pereira, Ramalho, Leandra Náira Zambelli, Guerra, Nayrim Brizuela [UNESP], Mussagy, Cassamo Ussemane, Floriano, Juliana Ferreira [UNESP], Barbosa, Angélica Mércia Pascon, Rudge, Marilza Vieira Cunha, Silva, Rosângela Gonçalves [UNESP], Farhadi, Neda, Mohaghegh, Neda, Monirizad, Mahsa, Peirsman, Arne, Gomez, Alejandro, de Mendonça, Ricardo José, dos Santos, Lindomar Soares, Marcaccini, Andrea Marcia, Tognoli, Silvia, Binotto, Cibele Correia S., Domingues, Aline Natalia, Jucaud, Vadim, Mendes, Adriana Aparecida, Oliveira, Amanda Santos, Li, Bingbing, Herculano, Rondinelli Donizetti [UNESP]
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:Brasil
Institución:Universidade Estadual Paulista (UNESP)
Repositorio:Repositório Institucional da UNESP
Idioma:inglés
OAI Identifier:oai:repositorio.unesp.br:11449/300287
Acceso en línea:http://dx.doi.org/10.1016/j.ijbiomac.2025.142615
https://hdl.handle.net/11449/300287
Access Level:acceso abierto
Palabra clave:Collagen
Diabetic foot ulcers
Natural rubber latex
Pilot clinical study
Regenerative medicine
Wound healing
Descripción
Sumario: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.