Polidocanol foam with or without transdermal Nd:YAG 1064 nm laser for lower‑leg varicose veins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel study with blinded outcome assessment comparing polidocanol foam alone to polidocanol foam plus transdermal 1064 nm Nd:YAG laser for lower‑limb tributary varicose veins. After 1:1 randomization, the control arm receives 0.5% polidocanol foam and the intervention arm receives 0.25% polidocanol foam followed by transdermal laser application; a second session is allowed at 30 days if partial occlusion persists. The primary endpoint is venous occlusion at 30 days measured by Doppler ultrasound, with additional follow‑ups and assessments at 30, 90, and 180 days for pigmentation, pain, patient satisfaction, number of sessions, and adverse events. Standardized photographs are taken at baseline and each follow‑up to document aesthetic outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 21 to 75 years
* CEAP clinical class 1-3
* Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.
* Vein depth up to 4 mm from the skin surface.
* Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.
* Reflux limited to the target tributary.
* Body mass index (BMI) \< 35 km²/m²
* Able and willing to provide informed consent.

Exclusion Criteria:

* CEAP clinical class ≥ 4
* Axial reflux of the great or small saphenous vein requiring prior treatment
* Tributary vein diameter \< 2.5 mm or \> 4.0 mm on Doppler
* Tributary vein depth \> 4 mm from the skin surface
* Pregnancy or breastfeeding
* Known allergy or hypersensitivity to polidocanol
* History of deep vein thrombosis or pulmonary embolism in the last 6 months
* Use of anticoagulant therapy that cannot be safely interrupted
* Active skin infection or ulcer at the treatment site
* Autoimmune or connective tissue disease with active vasculitis
* BMI ≥ 35 kg/m²
* Inability to comply with follow-up visits
* Previous treatment of the target vein in the past 6 months (laser, foam, surgery, or microphlebectomy).

Where it's running

• Hospital Universitário Pedro Ernesto - UERJ
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting

Study contacts

• Principal investigator: Juliana Vieira, PhD — Hospital Universitário Pedro Ernesto - UERJ
• Study coordinator: Juliana de Miranda Vieira, PhD
• Email: juliana.vieira@hupe.uerj.br
• Phone: + 55 21 99972 2885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.