A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study

A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study

<b>Background</b>: Diabetic foot ulcers (DFUs) affect 25% of diabetes patients, with high risks of amputation (70%), recurrence (65% within 3–5 years), and mortality (50–70% at 5-years). Current treatments are limited by persistent inflammation, oxidative stress, and cost barriers. This...

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Main Authors: Thamis Fernandes Santana Gomes, Natália Carvalho Guimarães, Ludmilla Pinto Guiotti Cintra Abreu, Gabriella de Oliveira Silva, Vitória Regina Pereira da Silva, Franciéle de Matos da Silva, Fabiane Hiratsuka Veiga-Souza, Paulo Eduardo Narcizo de Souza, Mário Fabrício Fleury Rosa, Graziella Anselmo Joanitti, Suélia de Siqueira Rodrigues Fleury Rosa, Marcella Lemos Brettas Carneiro
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Pharmaceutics
Subjects:
curcumin
natural latex biomembrane
wound healing
ulcers
oxidative stress
clinical assay
Online Access:https://www.mdpi.com/1999-4923/17/6/772
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Summary:<b>Background</b>: Diabetic foot ulcers (DFUs) affect 25% of diabetes patients, with high risks of amputation (70%), recurrence (65% within 3–5 years), and mortality (50–70% at 5-years). Current treatments are limited by persistent inflammation, oxidative stress, and cost barriers. This study evaluates a bioactive dressing combining a natural latex-based (NLB) biomembrane (<i>Hevea brasiliensis</i>) with curcumin-loaded liposomes, exhibiting angiogenic and antimicrobial properties, and red LED (light-emitting diode) phototherapy (635–640 nm) to address these challenges. <b>Methods</b>: A pilot clinical trial randomized 15 DFU participants into three groups: Control (CG, <i>n</i> = 5, standard care); Experimental Group 1 (EG1, <i>n</i> = 5, NLB + LED, daily treatment); and Experimental Group 2 (EG2, <i>n</i> = 5, NLB-curcumin liposomes + LED, daily treatment). Outcomes included wound closure, inflammatory/oxidative markers, and therapy feasibility. Assessments at D0, D22, and D45 included hematological/biochemical profiling, reactive oxygen species (ROS), and wound area measures. <b>Results</b>: On day 45, GE2 showed an average ulcer contraction of 89.8%, while CG showed 32.8%, and GE1 showed 9.7%. Systemic ROS and biomarkers (C-reactive protein, leukocytes) showed no significant changes (<i>p</i> > 0.05), though transient inflammatory spikes occurred. The combined therapy (EG2) accelerated healing without direct biomarker correlations. <b>Conclusions</b>: These findings highlight the potential of this combined therapy as an accessible, cost-effective DFU treatment, warranting larger studies to optimize home-based protocols and elucidate mechanisms.
ISSN:1999-4923

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