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Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Sponsor: University of Nove de Julho
Summary
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects. Compression therapy is the standard treatment; however, healing may remain slow. Photobiomodulation is being investigated as an adjunctive treatment to promote tissue repair and wound healing. This prospective, randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation combined with compression therapy in the healing of lower-limb venous leg ulcers. A total of 102 participants will be randomly allocated in a 1:1 ratio to an Experimental Group (n=51), receiving active photobiomodulation plus compression therapy, or a Control Group (n=51), receiving sham photobiomodulation plus compression therapy. Treatment will be administered twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions. The primary outcome will be the percentage reduction in wound volume over 16 weeks, estimated from wound area and depth. Secondary outcomes will include percentage reduction in wound area, change in wound depth, complete wound healing, adverse events, wound quality assessed using the Bates-Jensen Wound Assessment Tool, pain intensity and rescue analgesic use, health-related quality of life assessed using the SF-36, clinical severity assessed using the Venous Clinical Severity Score, and direct treatment costs. Wound area will be measured using the ImitoWound® application.
Official title: Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
Key Details
Gender
All
Age Range
19 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-08
Completion Date
2027-07
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
Photobiomodulation Therapy
The e-Light IRL cluster device (DMC Equipamentos, Brazil; ANVISA No. 80030810174) contains eight emitters: four at 660 nm and four at 808 nm. Each emitter has an output power of 100 mW and delivers 6 J over 60 seconds. Total output power is 800 mW. The applicator will be positioned perpendicular to the wound bed and applied by direct contact through disposable transparent PVC film. Appropriate protective eyewear will be used. Participants will receive active photobiomodulation twice weekly on Mondays and Thursdays for 16 weeks, totaling 32 sessions.
Sham Photobiomodulation
This intervention uses sham photobiomodulation therapy with the same laser device as in the active group, but without emitting 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 the management of venous leg ulcers. This sham procedure is designed to mimic the active treatment without delivering any laser energy, serving as a placebo control.
Compression Therapy
All study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.
Locations (1)
Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina
Lençóis Paulista, São Paulo, Brazil