Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

Recruiting now · Not applicable

Conditions studied: Varicose Veins

In brief

This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.

Key facts

Study ID

NCT07276243

Run by

Hospital Universitario Pedro Ernesto

People needed

102

Starts

2026-03-24

Expected to finish

2027-12-30

Last updated by the study team

2026-05-05

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Hospital Universitário Pedro Ernesto - UERJ — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)

Full record on ClinicalTrials.gov

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