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

Vinicius Saura Cardoso; Pedro Renan de Souza Lima da Silveira; Cristiana Maria Dos Santos; Rebeca Barbosa da Rocha; Fuad Ahmad Hazime

doi:10.1016/j.cct.2021.106561

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

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

Authors

Vinicius Saura Cardoso¹, Pedro Renan de Souza Lima da Silveira², Cristiana Maria Dos Santos², Rebeca Barbosa da Rocha³, Fuad Ahmad Hazime⁴

Affiliations

¹ 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. Electronic address: vscfisio@ufpi.edu.br.
² Integrated Center of Medical Specialties, Parnaíba, PI, Brazil; Department of Physical Therapy, Biomedical Master Science Program, Federal University of Piaui, Parnaíba, PI, Brazil.
³ Integrated Center of Medical Specialties, Parnaíba, PI, Brazil.
⁴ 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.

PMID: 34487920
DOI: 10.1016/j.cct.2021.106561

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/cm² (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.

Keywords: Diabetic foot ulcers; GaAs 904 nm; Low-level laser therapy.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Diabetes Mellitus*
Diabetic Foot* / therapy
Double-Blind Method
Humans
Low-Level Light Therapy*
Randomized Controlled Trials as Topic
Treatment Outcome
Wound Healing

Associated data

ClinicalTrials.gov/NCT04246814