Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial.

PURPOSE: This study aimed to examine the impact of a 904 nm photobiomodulation (PBM) on diabetic ulcers using varying dosages. METHODS: The study was a randomized, double-blind, placebo-controlled clinical trial that compared treatments using PBM (GaAs 904 nm 30w) with three different energy densities (4 J/cm2; 8 J/cm2; 10 J/cm2) in the healing process of non-infected diabetic foot ulcers. Eighty volunteers (48.75% female; 58.5 ± 11.1 years) were randomized into three intervention groups treated with PBM and one control group (PBM placebo). Volunteers performed up 20 interventions with PBM, either placebo or actual, in conjunction with conventional therapy, which involved dressing the wound with Helianthus annuus vegetable oil. The primary variable was the ulcer size reduction rate. RESULTS: GaAs 904 nm PBM yielded a clinically and significant ulcer size rate reduction of diabetic foot ulcers, independently of energy density range (p < 0.05). However, 10 J/cm² had 60% of completely healed ulcers and the highest proportion of patients reaching 50% of ulcer reduction rate after 5 weeks of treatment. In addition, only 10 J/cm² showed a significant difference between control group after a 10-week follow-up (p < 0.05). CONCLUSION: GaAs 904 nm PBM was effective in treating diabetic foot ulcers in this study and a dosage of 10 J/cm², after a 10-week follow-up, proved to be the most effective compared to the other groups. CLINICAL TRIAL REGISTRATION NUMBER: NCT04246814.

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

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.