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

โ† Trials
๐Ÿงช

Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Nove de Julho
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Given the pathophysiological complexity of these injuries, therapeutic strategies capable of acting simultaneously on the local wound microenvironment and the systemic biological environment become relevant for optimizing tissue repair. This study aims to evaluate the effects of the association between transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation (FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled and prospective phase II clinical trial, with a sample of 20 participants allocated to experimental groups that will receive a

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Medical diagnosis of Diabetes Mellitus type 1 or 2; * Presence of a foot ulcer with duration โ‰ฅ 4 weeks, characterizing a chronic ulcer; * Age โ‰ฅ 18 years; * Ankle-brachial index compatible with adequate perfusion, allowing for the safe conduct of treatment; * Wagner Grade I or Wagner Grade II classification of DM ulcer * Ability to understand the objectives of the study and signature of the ICF (Informed Consent Form). - Exclusion Criteria: * Having more than one ulcer to be treated, regardless of etiology; * Presence of hematological diseases that may interfere with peripheral blood analysis, such as: hemolytic anemias, hemoglobinopathies (sickle cell anemia), leukemias, lymphomas, multiple myeloma, or other blood dyscrasias that may significantly interfere with cell morphology or peripheral blood analysis; * Active systemic infection at the time of enrollment; * Active neoplasia undergoing treatment or under investigation; * Use of immunosuppressants or corticosteroids; * Pregnant or breastfeeding women; * Use of photosensitizing medications; * Allergy or sensitivity to any of the study interventions; * Clinical signs of infection, necrosis, devitalized tissue, or wound colonization. * Acute clinical conditions that contraindicate participation, whether related or unrelated to DM.
๐Ÿ’Š

What it tests

  • PBM - Photobiomodulation
  • Placebo PBM
  • Standard Treatment
๐Ÿ“

Where

1 site
Universidade Estadual do Piaui
Teresina, 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