NCT07123285Recruiting
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- Aug 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- University of Nove de Julho
- Diseases
- High blood pressure
- NCT number
- NCT07123285
What you commit to
- Study type: Interventional
- Planned participants: 102
- From Aug 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ulcer of non-venous etiology.
- 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.
Other
- Pregnancy.
- Any complication during the procedure requiring discontinuation for participant safety.
Who the study is looking for
- 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.
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina Coordinator of this site? Confirm its status | Lençóis Paulista | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.