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.
Participants of either sex.
Age 19 to 85 years.
Lower-limb venous ulcer present for at least 6 weeks and not healed.
Ulcer without infection at enrollment.
Ulcer of non-venous etiology.
Pregnancy.
Severe lower-limb arterial disease.
Current use or initiation of another venous-ulcer treatment different from the study treatment.
Parallel
Photobiomodulation Therapy
DeviceThe 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
DeviceThis 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
Procedure/SurgeryAll study participants received standardized wound care and compression therapy using 30-mmHg compression stockings.
Percentage Reduction in Wound Volume
Percentage reduction in wound volume over 16 weeks. Volume will be calculated as wound area (cm²) multiplied by wound depth (cm). Area will be estimated using the modified ellipse formula: length × width × 0.785. Depth will be measured at the deepest point with a sterile graduated probe. Percentage reduction will be calculated as \[(baseline volume - follow-up volume) / baseline volume\] × 100. For wounds with depth ≤0.1 cm, depth will be classified as zero for volumetric analysis, and healing response will be evaluated using percentage reduction in wound area.
Adverse events
Any undesirable event related or potentially related to treatment or study procedures will be recorded and classified according to severity (mild, moderate, or severe), type, causal relationship to treatment, and frequency.
Bates-Jensen Wound Assessment Tool Score
Wound condition will be assessed using the Bates-Jensen Wound Assessment Tool. Thirteen wound characteristics are scored from 1 to 5, resulting in a total score from 13 to 65. Higher scores indicate worse wound condition.
Pain intensity
Local pain intensity will be measured using a 10-cm Visual Analog Scale immediately before and after each active or sham intervention. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Health-Related Quality of Life
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Eight domain scores and the Physical and Mental Component Summary scores will be calculated. Domain scores range from 0 to 100, with higher scores indicating better health status.
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