Transcutaneous and topical photobiomodulation for diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled phase II study enlists adults with diabetes and a chronic foot ulcer to compare standard dressing therapy versus a protocol that adds both transcutaneous and topical photobiomodulation. The goal is to see if the combined light-based treatments can improve healing by affecting the local wound environment and systemic factors related to diabetes. Participants will have ulcers present for at least four weeks, adequate blood flow confirmed, and will be followed under protocol-safe conditions. The trial is conducted at a university site in Teresina, Brazil, led by the University of Nove de Julho.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Medical diagnosis of Diabetes Mellitus type 1 or 2;
* Presence of a foot ulcer with duration ≥ 4 weeks, characterizing a chronic ulcer;
* Age ≥ 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.

Where it's running

• Universidade Estadual do Piaui
  Teresina, Piauí, Brazil Recruiting

Study contacts

• Study coordinator: Rebeca B Cecatto, Ph.D.
• Email: rebeca.boltes@gmail.com
• Phone: 11970842496

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.