AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

RecruitingNAAges 18 Years - 75 YearsAllUniversity of Nove de Julho
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 eva

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Photobiomodulation
  • Simulation of Photobiomodulation
  • Therapeutic education
๐Ÿ“

Where

1 site
Conjunto Hospitalar do Mandaqui
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy