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.
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.
Patients with ulcers of non-venous etiology;
Pregnant women;
Presence of severe arterial disease in the lower limbs.
Parallel
Photobiomodulation plus Compression Therapy
DeviceThis intervention uses a low-level laser device with 8 emitters, including 4 red emitters at 660 nm and 4 infrared emitters at 808 nm. Each emitter delivers 6 Joules of energy at 100 mW power, with a total power output of 800 mW. Treatment is administered twice weekly over 16 weeks, totaling 32 sessions per participant. The device is used in combination with standard compression therapy for venous leg ulcer management.
Compression Therapy plus Sham Photobiomodulation
DeviceThis intervention uses a sham photobiomodulation therapy with the same laser device used in the active group but without emission of therapeutic laser light (inactive device). The device appears identical and the treatment sessions are conducted twice weekly over 16 weeks, totaling 32 sessions per participant. Participants also receive standard compression therapy for venous leg ulcer management. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.
Complete healing or reduction in venous ulcer size
Defined as total re-epithelialization of the wound with no drainage and no need for dressings, or a significant reduction in wound size by the end of the treatment period.
Adverse events
Adverse events will be recorded and classified according to severity (mild, moderate, severe) and relationship to the intervention. Frequency and type of events will be analyzed for both groups.
Wound quality assessment using the Bates-Jensen Wound Assessment Tool
Wound quality will be assessed using the Bates-Jensen Wound Assessment Tool, which evaluates parameters such as wound size, depth, edges, exudate, and tissue type. Assessments will be conducted at four time points to monitor healing progression.
Pain intensity measured by Visual Analog Scale
Pain intensity will be measured using the Visual Analog Scale (VAS). The VAS is a 10-centimeter line anchored by two extremes: 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate greater pain intensity (worse outcome). Measurements will be recorded before and after each laser or sham session. In addition, the frequency and total dosage of paracetamol (acetaminophen) use will be documented throughout the study period to evaluate analgesic consumption related to pain control.
Quality of life assessment using SF-36 questionnaire
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), which evaluates eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, emotional well-being, social functioning, pain, and general health perceptions. Each domain score ranges from 0 to 100, with higher scores indicating better health status and quality of life.
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