Effect of Using Photobiomodulation (660 Nanometers) for the Treatment of Diabetic Ulcers: Protocol for a Randomized Controlled Trial.
Mariana Bezerra Miranda, Rebeca Barbosa da Rocha, Rayana Fontenele Alves et al.
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In 30 seconds
This publication describes a protocol for a double-blind randomized clinical trial of photobiomodulation therapy in patients with diabetic foot ulcers. One hundred patients are planned for allocation to four groups: three groups receiving 660-nm laser treatment at different fluences (4, 8, or 12 J/cm²) and a comparator group receiving 904-nm treatment at 10 J/cm². Treatment is planned for 20 sessions over 10 weeks. The primary outcomes are ulcer healing rate and University of Texas classification scores; the abstract reports no trial results.
Key findings
- The protocol plans to randomize 100 patients with diabetic foot ulcers across four treatment groups.
- Three groups will receive 660-nm photobiomodulation at 4, 8, or 12 J/cm²; the comparator group will receive 904-nm treatment at 10 J/cm².
- Ulcer healing rate and University of Texas classification scores are the primary outcomes; no efficacy results are reported.
Why it matters
Diabetic foot ulcers can have substantial effects on quality of life and may recur despite prolonged treatment. This trial is designed to compare different photobiomodulation parameters and assess ulcer healing, potentially adding evidence about whether wavelength and fluence matter. As a protocol, it establishes the planned evaluation rather than demonstrating benefit.
What to keep in mind
This is a trial protocol, so it provides no outcome data or evidence of treatment efficacy.