Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2025-12-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over 60 days, and will receive therapeutic education.

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.

Participants will be assessed at the beginning of the study (baseline) and after 30 days (clinical examination) and 60 days (clinical examination, assessment of Peripheral neuropathy, assessment of peripheral artery disease, blood and urine tests, and quality of life evaluation).

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

* 1 physician-researcher who will conduct all initial evaluations and follow-up examinations (excluding Doppler ultrasound, Ankle-Brachial Index - ABI, and Toe-Brachial Index - TBI), without knowledge of the subjects' allocation, and will administer the Informed Consent Form (ICF).
* 1 Vascular surgeon researcher who will perform Doppler ultrasound, Ankle-Brachial Index (ABI), and Toe-Brachial Index (TBI) measurements during the initial assessment and follow-up examinations, without knowledge of the subjects' allocation.
* 1 Nurse researcher who will retrieve the allocation envelope and provide the appropriate PBM equipment (active or placebo), as well as provide recommendations for its use at home.
* 1 Researcher, who will not participate in any assessments, will prepare randomization and envelopes to ensure allocation confidentiality.
* 2 physician residents who will provide daily contact for device usage control, guidance, addressing inquiries, etc.

Study Groups

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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.

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type DEVICE

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.

Therapeutic education

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

Simulation of Photobiomodulation

Intervention Type DEVICE

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.

Therapeutic education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Therapeutic education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No