Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

NCT06353568 | Recruiting

• 1 other identifier: 5.888.210
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Foot

Keywords

photobiomodulation; diabetes mellitus; therapeutic education; LED light

Outcome Measures

Primary Outcomes (3)

• Ulcer Incidence

  The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

  Baseline (Before the intervention)

• Ulcer Incidence

  The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

  at 30 days

• Ulcer Incidence

  The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

  at 60 days

Secondary Outcomes (24)

• Tactile sensitivity with Semmes-Weinstein monofilament

  Baseline (Before the intervention)

• Tactile sensitivity with Semmes-Weinstein monofilament

  at 60 days

• Vibratory sensitivity

  Baseline (Before the intervention)

• Vibratory sensitivity

  at 60 days

• Assessment of Achilles reflex

  Baseline (Before the intervention)

Study Arms (2)

Photobiomodulation Group

EXPERIMENTAL

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.

Device: Photobiomodulation; Behavioral: Therapeutic education

Control Group

SHAM COMPARATOR

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.

Device: Simulation of Photobiomodulation; Behavioral: Therapeutic education

Interventions

Photobiomodulation 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.

Photobiomodulation Group

Simulation of Photobiomodulation 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.

Control Group

Therapeutic education BEHAVIORAL

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

Control Group; Photobiomodulation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Pregnant women
• Individuals diagnosed with type 1 diabetics,
• Individuals with neuropathy secondary to uncontrolled conditions (hypothyroidism, vitamin B12 deficiency, alcoholism),
• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Conjunto Hospitalar do Mandaqui

São Paulo, São Paulo, 02401-400, Brazil

RECRUITING

Related Publications (1)

• Lourenco R, Perez ST, Motta LJ, Duran CCG, Padilha ARS, Bussadori SK, Malavazzi TCDS, Horliana ACRT, Mesquita-Ferrari RA, Fernandes KPS. Effect of photobiomodulation as preventive treatment of diabetic foot ulcer: randomised, controlled, double-blind, clinical trial protocol. BMJ Open. 2025 Jan 22;15(1):e094594. doi: 10.1136/bmjopen-2024-094594.

  PMID: 39843368 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Kristianne KS Fernandes, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristianne KS Fernandes, PhD

CONTACT

+55 011 33859287; kristianneporta@gmail.com

Roselene Lourenço, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 9, 2024
• Study Start: March 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

BR (1)