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Study identifier: NCT06353568 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

Condition: Diabetic Foot  ·  Sponsor: University of Nove de Julho

PhaseNA
Planned participants64
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life).

This description comes directly from the study's public registry record.

Talk to the study team

Kristianne KS Fernandes, PhD  ·  +55 011 33859287  ·  kristianneporta@gmail.com

Roselene Lourenço, PhD

Always discuss trial participation with your own doctor first.

Locations (1)

Conjunto Hospitalar do MandaquiSão Paulo, São Paulo, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT06353568