Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial
Autor: | Pedro Renan de Souza Lima da Silveira, Cristiana Maria dos Santos, Fuad Ahmad Hazime, Vinicius Saura Cardoso, Rebeca Barbosa da Rocha |
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Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
medicine.medical_treatment Placebo law.invention Randomized controlled trial Laser therapy Double-Blind Method law medicine Diabetes Mellitus Humans Pharmacology (medical) Low-Level Light Therapy Trial registration Low level laser therapy Randomized Controlled Trials as Topic Protocol (science) Wound Healing business.industry General Medicine medicine.disease Diabetic foot Diabetic Foot Treatment Outcome Physical therapy business After treatment |
Zdroj: | Contemporary clinical trials. 110 |
ISSN: | 1559-2030 |
Popis: | 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. |
Databáze: | OpenAIRE |
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