Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Individuals diagnosed with type 2 Diabetes Mellitus (according to American Diabetes Association 2021 criteria),

• both sexes,

• between 18 and 75 years,

• Individuals classified, according to the International Working Group on the Diabetic Foot (IWGDF- 2019) scale, as moderate to high risk for developing diabetic foot,

Locations
Other Locations
Brazil
Conjunto Hospitalar do Mandaqui
RECRUITING
São Paulo
Contact Information
Primary
Kristianne KS Fernandes, PhD
kristianneporta@gmail.com
+55 011 33859287
Backup
Roselene Lourenço, PhD
Time Frame
Start Date: 2024-03-30
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 64
Treatments
Experimental: Photobiomodulation Group
The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over a period of 60 days, and will receive therapeutic education.
Sham_comparator: Control Group
The Control Group will use a non-therapeutic LED boot (placebo) for 6 minutes once daily for 60 days and will also receive therapeutic education.
Sponsors
Leads: University of Nove de Julho

This content was sourced from clinicaltrials.gov