Effect of Photobiomodulation as a Preventive Treatment for 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

Inclusion Criteria:

* 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,

Exclusion Criteria:

* Pregnant women
* Individuals diagnosed with type 1 diabetics,
* Individuals with neuropathy secondary to uncontrolled conditions (hypothyroidism, vitamin B12 deficiency, alcoholism),
* Individuals diagnosed with active infectious condition at the time of inclusion,
* Individuals diagnosed with active ulcer or infectious skin lesion on the legs/feet,
* Individuals with historic of osteomyelitis,
* Individuals with Parkinson's disease,
* Individuals with contracture condition,
* Individuals with severe lower limb ischemia (Fontaine III and IV - Rutherford 4 to 6),
* Individuals with a suspicious skin lesion for neoplasms or cutaneous dysplasias on the legs/feet
* Individuals diagnosed with oncologic disease or undergoing treatment within the last 3 (three) months,
* Individuals presenting unstable angina, recent acute myocardial infarction, history of severe arrhythmia within the last six months,
* Individuals diagnosed with decompensated Chronic Obstructive Pulmonary Disease (COPD),
* Inability to understand the ICF,
* Inability to attend appointments regularly.

Conditions2

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