Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

University of Nove de Julho

Status: Enrolling

Conditions: Diabetic Foot

Treatments: Behavioral: Therapeutic education; Device: Photobiomodulation; Device: Simulation of Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06353568

5.888.210

Details and patient eligibility

About

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).

Full description

Diabetic foot (DF) prevention involves risk classification, systemic care, assessment of Peripheral Artery Disease (PAD) and Peripheral Neuropathy (PN), regular foot examination, therapeutic education, and routine use of appropriate footwear. Photobiomodulation (PBM) has been successfully applied in the healing of DF. In addition to the therapeutic effects of PBM, its preventive effects have attracted the attention of researchers. This study seeks to evaluate the effect of PBM in the prevention of 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 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 and after 30 days (clinical examination) and 60 days (clinical examination, PN assessment, PAD assessment, blood and urine tests, and quality of life). The collected data will be stored, and organized in a repository and the appropriate statistical tests will be applied for each specific analysis. In all tests, a significance level of 5% will be adopted.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 2 patient groups

Photobiomodulation Group

Experimental group

Description:

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.

Treatment:

Device: Photobiomodulation

Behavioral: Therapeutic education

Control Group

Sham Comparator group

Description:

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.

Treatment:

Device: Simulation of Photobiomodulation

Behavioral: Therapeutic education