Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

NARecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

March 30, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

December 30, 2025

Conditions
Diabetic Foot
Interventions
DEVICE

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.

DEVICE

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.

BEHAVIORAL

Therapeutic education

Participants will receive therapeutic education regarding nutrition, foot examination, self-care, and guidance on physical activity.

Trial Locations (1)

02401-400

RECRUITING

Conjunto Hospitalar do Mandaqui, São Paulo

All Listed Sponsors
lead

University of Nove de Julho

OTHER