Photobiomodulation plus compression for venous leg ulcers
Official title: Effect of Photobiomodulation on the Healing of Lower-Limb Venous Ulcers: A Randomized, Double-Blind, Controlled Clinical Trial
Run by University of Nove de Julho · NCT07123285 · Data updated 2026-11-12
This trial tests whether adding photobiomodulation to standard compression therapy helps healing venous leg ulcers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 85 Years |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (Lençóis Paulista, São Paulo) |
| Status | Recruiting |
| Started | August 3, 2026 |
| Main results expected | November 30, 2027 |
| Study ends | March 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07123285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–85 with a lower-limb venous ulcer present for at least 6 weeks, not infected, and with adequate arterial perfusion.
✕Probably not a fit
Patients with non-venous ulcers, moderate to severe arterial disease, infection, or those not adherent to dressings and compression may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind trial compares active photobiomodulation plus compression to sham photobiomodulation plus compression in adults with non-infected, non-arterial-compromised venous leg ulcers. Participants receive treatment twice weekly for 16 weeks, with wound care and compression identical across groups. The primary outcome is the percentage reduction in wound volume over 16 weeks. The study aims to determine if photobiomodulation can accelerate healing beyond standard wound care and compression. The trial is conducted at a single Brazilian site with 102 participants total.
Why it matters
Potential benefit: If successful, participants may experience faster ulcer healing and reduced pain and functional limitation.
How similar studies have gone: Previous research in related wound therapies suggests potential benefits from photobiomodulation when combined with compression, though results vary by protocol and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Criteria * 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's running
-
Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina
Lençóis Paulista, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Rayana G Moreira, MD
- Email: rayanamoreira@hotmail.com
- Phone: +5514981051703
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.