RecruitingNot ApplicableNCT06353568

Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

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

Sponsor

University of Nove de Julho

Enrollment

64 participants

Start Date

Mar 30, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Photobiomodulation, a medical device called Simulation of Photobiomodulation, and others for people with diabetic foot. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotobiomodulation

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.

DEVICESimulation 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.

BEHAVIORALTherapeutic education

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