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

Abstract

This study aimed to examine the impact of a 904nm photobiomodulation (PBM) on diabetic ulcers using varying dosages. The study was a randomized, double-blind, placebo-controlled clinical trial that compared treatments using PBM (GaAs 904nm 30w) with three different energy densities (4J/cm2; 8J/cm2; 10J/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. GaAs 904nm PBM yielded a clinically and significant ulcer size rate reduction of diabetic foot ulcers, independently of energy density range (p < 0.05). However, 10J/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 10J/cm² showed a significant difference between control group after a 10-week follow-up (p < 0.05). GaAs 904nm PBM was effective in treating diabetic foot ulcers in this study and a dosage of 10J/cm², after a 10-week follow-up, proved to be the most effective compared to the other groups. NCT04246814.