Contemporary clinical trials · 2021
Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Cardoso Vinicius Saura, de Souza Lima da Silveira Pedro Renan, Dos Santos Cristiana Maria, da Rocha Rebeca Barbosa, Hazime Fuad Ahmad
Аннотация
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.
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.