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
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Language:English
Published: MDPI AG 2025-06-01
Series:Pharmaceutics
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Online Access:https://www.mdpi.com/1999-4923/17/6/772
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author 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
author_facet 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
author_sort Thamis Fernandes Santana Gomes
collection DOAJ
description <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.
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spelling doaj-art-8fbd8e95e5644099a489e0bd56cc29be2025-08-20T02:21:49ZengMDPI AGPharmaceutics1999-49232025-06-0117677210.3390/pharmaceutics17060772A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical StudyThamis Fernandes Santana Gomes0Natália Carvalho Guimarães1Ludmilla Pinto Guiotti Cintra Abreu2Gabriella de Oliveira Silva3Vitória Regina Pereira da Silva4Franciéle de Matos da Silva5Fabiane Hiratsuka Veiga-Souza6Paulo Eduardo Narcizo de Souza7Mário Fabrício Fleury Rosa8Graziella Anselmo Joanitti9Suélia de Siqueira Rodrigues Fleury Rosa10Marcella Lemos Brettas Carneiro11Laboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Protein Chemistry and Biochemistry, Department of Cell Biology, Institute of Biology, University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Microscopy and Microanalysis, Department of Cell Biology, Institute of Biological Sciences, University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Protein Chemistry and Biochemistry, Department of Cell Biology, Institute of Biology, University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Electron Paramagnetic Resonance, Institute of Physics, University of Brasilia, Brasilia 70910-900, DF, BrazilPostgraduate Program in Biomedical Engineering at Gama-FGA, University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, BrazilPostgraduate Program in Biomedical Engineering at Gama-FGA, University of Brasilia, Brasilia 70910-900, DF, BrazilLaboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, Brazil<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.https://www.mdpi.com/1999-4923/17/6/772curcuminnatural latex biomembranewound healingulcersoxidative stressclinical assay
spellingShingle 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
A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
Pharmaceutics
curcumin
natural latex biomembrane
wound healing
ulcers
oxidative stress
clinical assay
title A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
title_full A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
title_fullStr A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
title_full_unstemmed A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
title_short A Natural Latex-Based Smart Dressing for Curcumin Delivery Combined with LED Phototherapy in Diabetic Foot Ulcers: A Pilot Clinical Study
title_sort natural latex based smart dressing for curcumin delivery combined with led phototherapy in diabetic foot ulcers a pilot clinical study
topic curcumin
natural latex biomembrane
wound healing
ulcers
oxidative stress
clinical assay
url https://www.mdpi.com/1999-4923/17/6/772
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