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Effect of Photobiomodulation on Healing of Venous Leg Ulcers

RecruitingNAAges 19 Years - 85 YearsAllUniversity of Nove de Julho
NCT07123285 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, t

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📋 Eligibility rules (as published)
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.
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What it tests

  • Photobiomodulation Therapy
  • Sham Photobiomodulation
  • Compression Therapy
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Where

1 site
Estratégia Saúde da Família Vereador Carlos Alberto Baptistela - Maria Cristina
Lençóis Paulista, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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