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Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Sponsor: University of Nove de Julho
Summary
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.
Official title: Effect of Photobiomodulation on the Healing of Venous Ulcers in the Lower Limbs
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-03
Completion Date
2027-07
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
Photobiomodulation plus Compression Therapy
This 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
This 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.
Locations (1)
Estratégia da Saúde da Família Monte Azul - "Antonio Benedetti".
Lençóis Paulista, São Paulo, Brazil