低水平激光治疗糖尿病足溃疡愈合的剂量反应和疗效：一项随机对照试验的方案。

Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial.

机构信息

Integrated Center of Medical Specialties, Parnaíba, PI, Brazil; Biomedical Master Science Program, Federal University of Piaui, Parnaíba, PI, Brazil; Department of Physical Therapy, Biomedical Master Science Program, Federal University of Piaui, Parnaíba, PI, Brazil.

Integrated Center of Medical Specialties, Parnaíba, PI, Brazil; Department of Physical Therapy, Biomedical Master Science Program, Federal University of Piaui, Parnaíba, PI, Brazil.

出版信息

Contemp Clin Trials. 2021 Nov;110:106561. doi: 10.1016/j.cct.2021.106561. Epub 2021 Sep 4.

DOI:10.1016/j.cct.2021.106561

PMID:34487920

Abstract

BACKGROUND

Current evidence shows that low-level laser therapy (LLLT) is an effective non-invasive and non-pharmacological strategy to treat diabetic foot ulcers (DFU). However, knowledge of parameterization efficacy remains unclear.

METHODS

This randomized, double-blind, controlled trial will be conducted at the Physical Therapy University Clinic. Eighty volunteers will be randomized into four groups. The control group will receive placebo LLLT + conventional treatment. The three active groups will receive 10 (G10), 8 (G8), or 4 J/cm (G4) of GaAs 904 nm LLLT plus conventional treatment twice a week for 20 sessions. Conventional treatment involves cleaning and dressing the ulcers. The main outcome will be the area of ulcers and Wagner classification score. Assessments will take place before treatment, after 5 and 10 weeks of treatment, and in the third month after treatment, by a blinded evaluator.

IMPLICATIONS

This trial can potentially provide important information and assist in clinical decision-making regarding DFU treatment with LLLT.

TRIAL REGISTRATION

NCT04246814, registered 29th January 2020.

摘要

背景

目前的证据表明，低水平激光疗法（LLLT）是一种治疗糖尿病足溃疡（DFU）的有效、非侵入性和非药物策略。然而，关于参数化疗效的知识仍不清楚。

方法

这项随机、双盲、对照试验将在理疗大学诊所进行。80 名志愿者将被随机分为四组。对照组将接受安慰剂 LLLT+常规治疗。三个活性组将接受 10（G10）、8（G8）或 4J/cm 的 GaAs 904nm LLLT+每周两次共 20 次的常规治疗。常规治疗包括清洁和包扎溃疡。主要结局将是溃疡面积和 Wagner 分类评分。由盲法评估者在治疗前、治疗后 5 周和 10 周以及治疗后第三个月进行评估。