Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation, Simulation of Photobiomodulation, Therapeutic education.
- Who it may be relevant to
- Registry conditions: Diabetic Foot. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study
Overview
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).
Detailed 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.
Interventions
- Device 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. - 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. - Behavioral Therapeutic education
Participants will receive therapeutic education regarding nutrition, foot examination, self-care, and guidance on physical activity.
Primary outcome measures
- Ulcer Incidence [Time frame: Baseline (Before the intervention)]
- Ulcer Incidence [Time frame: at 30 days]
- Ulcer Incidence [Time frame: at 60 days]
Secondary outcome measures (12)
- Tactile sensitivity with Semmes-Weinstein monofilament [Time frame: Baseline (Before the intervention)]
- Tactile sensitivity with Semmes-Weinstein monofilament [Time frame: at 60 days]
- Vibratory sensitivity [Time frame: Baseline (Before the intervention)]
- Vibratory sensitivity [Time frame: at 60 days]
- Assessment of Achilles reflex [Time frame: Baseline (Before the intervention)]
- Assessment of Achilles reflex [Time frame: at 60 days]
- Neuropathy Symptom Score (NSS) [Time frame: Baseline (Before the intervention)]
- Neuropathy Symptom Score (NSS) [Time frame: at 60 days]
- Neuropathic Impairment Score (NIS) [Time frame: Baseline (Before the intervention)]
- Neuropathic Impairment Score (NIS) [Time frame: at 60 days]
- Evaluation of the degree of ischemia [Time frame: Baseline (Before the intervention)]
- Evaluation of the degree of ischemia [Time frame: at 60 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Conjunto Hospitalar do Mandaqui — São Paulo
Publications
- 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
Identifiers
NCT: NCT06353568 · 5.888.210