Effect of Photobiomodulation on Healing of Venous Leg Ulcers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Nove de Julho

About this trial

This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 96 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p \< 0.05.

Eligibility criteria

Qualifiers

Patients of both sexes;

Individuals with venous ulcers in the lower limbs for at least three weeks that have not healed;

Age between 18 and 85 years;

Residents of Lençóis Paulista or nearby regions.

Disqualifiers

Patients with ulcers of non-venous etiology;

Pregnant women;

Presence of severe arterial disease in the lower limbs.

Trial design

Treatments tested in this trial

  • Photobiomodulation plus Compression Therapy
  • Compression Therapy plus Sham Photobiomodulation

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators