64
Participants
Start Date
March 30, 2024
Primary Completion Date
June 30, 2025
Study Completion Date
December 30, 2025
Photobiomodulation
The PBM Group will use a boot with 1344 LEDs, including 504 LEDs of 660 nm located on the sides of the boot (28.5 mW, 10 J per LED); 504 LEDs of 850 nm also located on the sides of the boot (23 mW, 8 J per LED); 168 LEDs of 660 nm located at the base of the boot (28.5 mW, 10 J per LED); and 168 LEDs of 850 nm also located at the base of the boot (23 mW, 8 J per LED) once daily for 6 minutes, over 60 days.
Simulation of Photobiomodulation
The Control Group will use a non-therapeutic LED boot (sham procedure) for 6 minutes once daily for 60 days. The boot used is identical to the active boot, but there is no light emission.
Therapeutic education
Participants will receive therapeutic education regarding nutrition, foot examination, self-care, and guidance on physical activity.
RECRUITING
Conjunto Hospitalar do Mandaqui, São Paulo
University of Nove de Julho
OTHER