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一种基于天然乳胶的用于姜黄素递送并结合LED光疗治疗糖尿病足溃疡的智能敷料:一项初步临床研究。

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

作者信息

Gomes Thamis Fernandes Santana, Guimarães Natália Carvalho, Abreu Ludmilla Pinto Guiotti Cintra, Silva Gabriella de Oliveira, da Silva Vitória Regina Pereira, da Silva Franciéle de Matos, Veiga-Souza Fabiane Hiratsuka, de Souza Paulo Eduardo Narcizo, Rosa Mário Fabrício Fleury, Joanitti Graziella Anselmo, Fleury Rosa Suélia de Siqueira Rodrigues, Carneiro Marcella Lemos Brettas

机构信息

Laboratory of Bioactive Compounds and Nanobiotechnology (LCBNano), University of Brasilia, Brasilia 70910-900, DF, Brazil.

Laboratory of Protein Chemistry and Biochemistry, Department of Cell Biology, Institute of Biology, University of Brasilia, Brasilia 70910-900, DF, Brazil.

出版信息

Pharmaceutics. 2025 Jun 12;17(6):772. doi: 10.3390/pharmaceutics17060772.

DOI:10.3390/pharmaceutics17060772
PMID:40574084
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12196574/
Abstract

: 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 () with curcumin-loaded liposomes, exhibiting angiogenic and antimicrobial properties, and red LED (light-emitting diode) phototherapy (635-640 nm) to address these challenges. : A pilot clinical trial randomized 15 DFU participants into three groups: Control (CG, = 5, standard care); Experimental Group 1 (EG1, = 5, NLB + LED, daily treatment); and Experimental Group 2 (EG2, = 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. : 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 ( > 0.05), though transient inflammatory spikes occurred. The combined therapy (EG2) accelerated healing without direct biomarker correlations. : 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.

摘要

糖尿病足溃疡(DFUs)影响25%的糖尿病患者,截肢风险高(70%)、复发风险高(3至5年内为65%)以及死亡率高(5年时为50 - 70%)。当前的治疗受到持续炎症、氧化应激和成本障碍的限制。本研究评估了一种生物活性敷料,其将基于天然乳胶的(NLB)生物膜与负载姜黄素的脂质体相结合,具有血管生成和抗菌特性,以及红色发光二极管(LED)光疗(635 - 640纳米),以应对这些挑战。:一项试点临床试验将15名DFU参与者随机分为三组:对照组(CG,n = 5,标准护理);实验组1(EG1,n = 5,NLB + LED,每日治疗);实验组2(EG2,n = 5,NLB - 姜黄素脂质体 + LED,每日治疗)。结果包括伤口闭合、炎症/氧化标记物以及治疗可行性。在第0天、第22天和第45天的评估包括血液学/生化分析、活性氧(ROS)以及伤口面积测量。:在第45天,EG2显示平均溃疡收缩率为89.8%,而CG为32.8%,EG1为9.7%。全身ROS和生物标志物(C反应蛋白、白细胞)虽有短暂炎症峰值,但无显著变化(P > 0.05)。联合治疗(EG2)加速了愈合,且与生物标志物无直接关联。:这些发现凸显了这种联合治疗作为一种可及、具有成本效益的DFU治疗方法的潜力,需要进行更大规模的研究以优化家庭治疗方案并阐明其机制。

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