Clinical trial NCT06353568: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot
Official title: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Keywords: photobiomodulation
diabetes mellitus
therapeutic education
LED light
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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).

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.

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.

Primary outcomes:
measure: Ulcer Incidence
timeFrame: Baseline (Before the intervention)
measure: Ulcer Incidence
timeFrame: at 30 days
measure: Ulcer Incidence
timeFrame: at 60 days
Secondary outcomes:
measure: Tactile sensitivity with Semmes-Weinstein monofilament
timeFrame: Baseline (Before the intervention)
measure: Tactile sensitivity with Semmes-Weinstein monofilament
timeFrame: at 60 days
measure: Vibratory sensitivity
timeFrame: Baseline (Before the intervention)
measure: Vibratory sensitivity
timeFrame: at 60 days
measure: Assessment of Achilles reflex
timeFrame: Baseline (Before the intervention)
measure: Assessment of Achilles reflex
timeFrame: at 60 days
measure: Neuropathy Symptom Score (NSS)
timeFrame: Baseline (Before the intervention)
measure: Neuropathy Symptom Score (NSS)
timeFrame: at 60 days
measure: Neuropathic Impairment Score (NIS)
timeFrame: Baseline (Before the intervention)
measure: Neuropathic Impairment Score (NIS)
timeFrame: at 60 days
measure: Evaluation of the degree of ischemia
timeFrame: Baseline (Before the intervention)
measure: Evaluation of the degree of ischemia
timeFrame: at 60 days
measure: Systolic peak velocity
timeFrame: Baseline (Before the intervention)
measure: Systolic peak velocity
timeFrame: at 60 days
measure: Resistance Index
timeFrame: Baseline (Before the intervention)
measure: Resistance Index
timeFrame: at 60 days
measure: Waveform pattern
timeFrame: Baseline (Before the intervention)
measure: Waveform pattern
timeFrame: at 60 days
measure: Evaluation of claudication
timeFrame: Baseline (Before the intervention)
measure: Evaluation of claudication
timeFrame: at 60 days
measure: Thermography
timeFrame: Baseline (Before the intervention)
measure: Thermography
timeFrame: at 60 days
measure: Quality of Life Assessment
timeFrame: Baseline (Before the intervention)
measure: Quality of Life Assessment
timeFrame: at 60 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Conjunto Hospitalar do Mandaqui
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Kristianne KS Fernandes, PhD
role: PRINCIPAL_INVESTIGATOR
References: