Dose-response and efficacy of 830-nanometer photobiomodulation in healing diabetic foot ulcers: randomized, double-blind, clinical trial protocol.

Diabetic foot ulcers (DFUs) cause limitations in physical functioning and performance of activities of daily living (ADLs), accompanied by high emotional burden, anxiety, and depression. Furthermore, persistent and recurrent ulcers, severe amputations, and limitations in ambulation are associated with a significant impact on the quality of life (QOL) and economic burden. Photobiomodulation (PBM) has emerged as a painless, noninvasive, and low-cost option. The biostimulatory and bioinhibitory effects of PBM depend on the parameters used. This double-blind, randomized clinical trial will be conducted at the Integrated Center of Medical Specialties. One Hundred and thirty-six volunteers will be randomized into four groups. GaAlAs 830 nm, 30 mW, in continuous mode (IBRAMED®) with three energy densities (4 J/cm², 8 J/cm², or 12 J/cm²) will be used. The control group will use 904 nm GaAs, 70 mW, and an energy density of 10 J/cm² (ENDOPHOTON KLD) in pulsed mode, for two non-consecutive days per week for 10 weeks, totaling 20 sessions. The primary outcomes will be ulcer reduction and healing rates. Secondary outcomes will be the University of Texas classification, blood glucose levels, quality of life, healing time, time to recurrence, and viability. Ulcers will be assessed at day 1, 5 weeks, 10 weeks of treatment, and at a 12-week follow-up after treatment completion. The results of the proposed study may provide relevant evidence on the effective parameterization and feasibility of photobiomodulation as an accessible and applicable therapeutic resource in the clinical practice of DFUs.