Actively Recruiting
Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
Led by Hospital Universitario Pedro Ernesto · Updated on 2026-05-05
102
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 75 years
- CEAP clinical class 1 to 3
- Lower limb tributary varicose veins 2.5 to 4.0 mm in diameter confirmed by Doppler ultrasound
- Vein depth up to 4 mm from the skin surface
- Tributary vein may originate from the great or small saphenous vein if the saphenous vein is competent on Doppler
- Reflux limited to the target tributary vein
- Body mass index (BMI) less than 35 kg/m²
- Able and willing to provide informed consent
You will not qualify if you...
- CEAP clinical class 4 or higher
- Axial reflux of the great or small saphenous vein requiring prior treatment
- Tributary vein diameter less than 2.5 mm or greater than 4.0 mm on Doppler ultrasound
- Tributary vein depth greater than 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
- Body mass index (BMI) 35 kg/m² or higher
- Inability to comply with follow-up visits
- Previous treatment of the target vein in the past 6 months (laser, foam, surgery, or microphlebectomy)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
Actively Recruiting
Research Team
J
Juliana de Miranda Vieira, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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