protocolSection identificationModule nctId: NCT06353568, orgStudyIdInfo id: 5.888.210, briefTitle: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-10-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Nove de Julho, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Diabetic Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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)., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: * 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., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, interventions name: Simulation of Photobiomodulation, interventions name: Therapeutic education, outcomesModule primaryOutcomes measure: Ulcer Incidence, primaryOutcomes measure: Ulcer Incidence, primaryOutcomes measure: Ulcer Incidence, secondaryOutcomes measure: Tactile sensitivity with Semmes-Weinstein monofilament, secondaryOutcomes measure: Tactile sensitivity with Semmes-Weinstein monofilament, secondaryOutcomes measure: Vibratory sensitivity, secondaryOutcomes measure: Vibratory sensitivity, secondaryOutcomes measure: Assessment of Achilles reflex, secondaryOutcomes measure: Assessment of Achilles reflex, secondaryOutcomes measure: Neuropathy Symptom Score (NSS), secondaryOutcomes measure: Neuropathy Symptom Score (NSS), secondaryOutcomes measure: Neuropathic Impairment Score (NIS), secondaryOutcomes measure: Neuropathic Impairment Score (NIS), secondaryOutcomes measure: Evaluation of the degree of ischemia, secondaryOutcomes measure: Evaluation of the degree of ischemia, secondaryOutcomes measure: Systolic peak velocity, secondaryOutcomes measure: Systolic peak velocity, secondaryOutcomes measure: Resistance Index, secondaryOutcomes measure: Resistance Index, secondaryOutcomes measure: Waveform pattern, secondaryOutcomes measure: Waveform pattern, secondaryOutcomes measure: Evaluation of claudication, secondaryOutcomes measure: Evaluation of claudication, secondaryOutcomes measure: Thermography, secondaryOutcomes measure: Thermography, secondaryOutcomes measure: Quality of Life Assessment, secondaryOutcomes measure: Quality of Life Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False