NOT YET RECRUITING
NCT07123285
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
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.
Gender: All
Ages: 18 Years - 85 Years
Venous Disease
Venous Insufficiency (Chronic)(Peripheral)
Venous Insufficiency of Leg
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