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

Author(s):Show less -

de Barros, Natan Roberto ; Chagas, Ana Laura Destro ; Forster, Samuel ; Brasil, Giovana Sant'Ana Pegorin ; Ribeiro, Geraldo Monteiro ; Olivato, Orestes Pereira ; Ramalho, Leandra Naira Zambelli ; Guerra, Nayrim Brizuela ; Mussagy, Cassamo Ussemane ; Floriano, Juliana Ferreira ; Barbosa, Angelica Mercia Pascon ; Rudge, Marilza Vieira Cunha ; Silva, Rosangela Goncalves ; Farhadi, Neda ; Mohaghegh, Neda ; Monirizad, Mahsa ; Peirsman, Arne ; Gomez, Alejandro ; de Mendonca, Ricardo Jose ; 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

• Document type: Journal article
• Source: International Journal of Biological Macromolecules; v. 308, p. 20-pg., 2025-05-01.

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. (AU)

• FAPESP's process: 17/19603-8 - Development of a novel patch containing latex and barbatimam e fractions and study of signaling pathways in cutaneous wound repair
• Grantee: Rondinelli Donizetti Herculano
• Support Opportunities: Regular Research Grants
• FAPESP's process: 11/17411-8 - Evaluation of drugs delivery systems using natural rubber latex membranes as carrier
• Grantee: Rondinelli Donizetti Herculano
• Support Opportunities: Regular Research Grants
• FAPESP's process: 23/17448-6 - "EMU: Acquisition of 3D bioprinting, laser cutting and fluorescence microscope for implementation of organs-on-a-chip and organoids facility"
• Grantee: Rondinelli Donizetti Herculano
• Support Opportunities: Research Infrastructure Program - Small Medium Sized
• FAPESP's process: 17/02518-8 - Development of polymer blends of latex-alginate and latex-collagen for tissue engineering application
• Grantee: Natan Roberto de Barros
• Support Opportunities: Scholarships in Brazil - Doctorate
• FAPESP's process: 18/07342-8 - Development of microfluidic devices/organ on a chip using xurography, poliester-toner and gelatin methacryloyl (GelMA)
• Grantee: Rondinelli Donizetti Herculano
• Support Opportunities: Scholarships abroad - Research