Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

Официальное название

Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Ulcer Incidence [Срок оценки: Baseline (Before the intervention)]
• Ulcer Incidence [Срок оценки: at 30 days]
• Ulcer Incidence [Срок оценки: at 60 days]

Вторичные конечные точки (12)

• Tactile sensitivity with Semmes-Weinstein monofilament [Срок оценки: Baseline (Before the intervention)]
• Tactile sensitivity with Semmes-Weinstein monofilament [Срок оценки: at 60 days]
• Vibratory sensitivity [Срок оценки: Baseline (Before the intervention)]
• Vibratory sensitivity [Срок оценки: at 60 days]
• Assessment of Achilles reflex [Срок оценки: Baseline (Before the intervention)]
• Assessment of Achilles reflex [Срок оценки: at 60 days]
• Neuropathy Symptom Score (NSS) [Срок оценки: Baseline (Before the intervention)]
• Neuropathy Symptom Score (NSS) [Срок оценки: at 60 days]
• Neuropathic Impairment Score (NIS) [Срок оценки: Baseline (Before the intervention)]
• Neuropathic Impairment Score (NIS) [Срок оценки: at 60 days]
• Evaluation of the degree of ischemia [Срок оценки: Baseline (Before the intervention)]
• Evaluation of the degree of ischemia [Срок оценки: at 60 days]

Критерии участия

Критерии включения

• 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,

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Conjunto Hospitalar do Mandaqui — São Paulo

Публикации

• 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

Идентификаторы

NCT: NCT06353568 · 5.888.210

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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