Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Starting soon · Not applicable · Has a placebo group
Conditions studied: Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency, Chronic Venous Disease
In brief
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.
Key facts
- Study ID
- NCT07123285
- Run by
- University of Nove de Julho
- People needed
- 102
- Starts
- 2026-08-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Operational confirmation before enrollment:
- Venous etiology confirmed by Doppler ultrasonography demonstrating venous reflux.
- Ankle-Brachial Index ≥0.8 to exclude concomitant arterial disease.
- Written informed consent.
You may not qualify if…
- 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.
- Protocol Discontinuation Criteria
- Wound worsening with onset of infection.
- Any complication during the procedure requiring discontinuation for participant safety.
Where it is running
- Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina — Lençóis Paulista, São Paulo, Brazil
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.