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采用红-红外光谱发光二极管(LED)光疗治疗糖尿病足溃疡:一项对照随机临床试验。

Photobiomodulation using red and infrared spectrum light emitting-diode (LED) for the healing of diabetic foot ulcers: a controlled randomized clinical trial.

机构信息

Postgraduate Program in Rehabilitation and Functional Performance, Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.

Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.

出版信息

Lasers Med Sci. 2024 Oct 9;39(1):253. doi: 10.1007/s10103-024-04199-5.

DOI:10.1007/s10103-024-04199-5
PMID:39382587
Abstract

Assessing the responses to the application of photobiomodulation using red and infrared spectrum light-emitting diodes (LED) on diabetic foot ulcers. Diabetic volunteers, of both genders, aged between 30 and 65 years, with grade I or II ulcers, were randomized into the groups: red LED, infrared LED, LED associated, and control. Home-based interventions took place on a daily basis for 12 weeks. Assessments of sample characterization were performed on day 1 and 90, and the variables wound healing index, mean skin temperature, sensitivity and pain in the wound area were measured at the pre-intervention time on days 1, 30, 60 and 90, with subsequent follow-up 30 days after the end of treatment. For statistical analysis, the software SPSS, version 17.0, intention-to-treat analysis, data normality was tested, and the linear mixed effects model, with a significance level of 5%. Magnitudes of clinical effect by Cohen's d. At the pre vs post intervention time of 90 days, we found a large clinical effect of G-LED V (d=1.7) and G -LED IV (d=1.6) in relation to G-C, where these intervention groups showed a tendency for faster wound healing compared to G-C. We also observed small clinical effect of G-LED IV, which showed greater reduction in the area in relation to G-LED V (d=0.4) and G-LED A (d=0.3). Conclusion: The use of individually applied red and infrared LED phototherapy clinically tended to be more effective for the reduction of diabetic foot ulcer areas, and infrared LED was the most effective. Trial registration: NCT03250533 (clinicaltrials.gov).

摘要

评估红、红外光谱发光二极管(LED)在糖尿病足溃疡中的应用反应。将年龄在 30 至 65 岁之间、性别不限、I 或 II 级溃疡的糖尿病志愿者随机分为红 LED 组、红外 LED 组、LED 联合组和对照组。家庭干预每天进行一次,持续 12 周。在第 1 天和第 90 天进行样本特征评估,在第 1、30、60 和 90 天的干预前时间测量伤口愈合指数、平均皮肤温度、伤口区域的敏感性和疼痛等变量,并在治疗结束后 30 天进行后续随访。对于统计分析,使用 SPSS 软件版本 17.0 进行意向治疗分析,数据正态性检验,采用线性混合效应模型,显著性水平为 5%。用 Cohen's d 评估临床效果的大小。在第 90 天的干预前和干预后时间,我们发现 G-LED V(d=1.7)和 G-LED IV(d=1.6)与 G-C 相比具有较大的临床效果,这些干预组与 G-C 相比表现出更快的伤口愈合趋势。我们还观察到 G-LED IV 具有较小的临床效果,与 G-LED V(d=0.4)和 G-LED A(d=0.3)相比,G-LED IV 显示出更大的面积减少。结论:单独应用红、红外 LED 光疗在临床上更倾向于减少糖尿病足溃疡面积,而红外 LED 是最有效的。试验注册:NCT03250533(clinicaltrials.gov)。

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伤口愈合的新进展:治疗进展与微生物见解
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