Light Therapy Added to Compression for Healing Venous Leg Ulcers
Tests light therapy with compression in adults with slow-healing venous leg ulcers.
Plain-language title generated from the registry record
Registry title: Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Key facts
- Where
- Lençóis Paulista, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 85 years old?
Source: NCT07123285, who can take part
Where in Brazil
- Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria CristinaLençóis Paulista, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Nove de Julho
- Trial code
- NCT07123285
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
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.
Inclusion: 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.
Exclusion: 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; Pregnancy; Any complication during the procedure requiring discontinuation for participant safety.