Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polidocanol foam sclerotherapy, Transdermal Nd:YAG 1064 nm laser.
- Who it may be relevant to
- Registry conditions: Varicose Veins. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
Overview
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.
Detailed description
The study aims to evaluate whether the association of transdermal Nd:YAG 1064 nm laser with polidocanol foam improves venous occlusion and aesthetic outcomes compared to foam alone. Participants will be adult patients with lower limb varicose veins CEAP 1-3 confirmed by Doppler ultrasound. After randomization (1:1), the control group will receive 0.5% polidocanol foam, while the intervention group will receive 0.25% polidocanol foam followed by transdermal laser application. A second session will be performed only if partial occlusion persists at the 30-day follow-up. Assessments will include venous occlusion at 30, 90 and 180 days after the procedure, pigmentation, pain intensity, number of sessions required, patient satisfaction, and adverse events. Standardized photographs will be taken at baseline, 30, 90 and 180 days.
Interventions
- Drug Polidocanol foam sclerotherapy
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance. - Device Transdermal Nd:YAG 1064 nm laser
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
Primary outcome measures
- Venous occlusion rate at 30 days [Time frame: 30 days after the first session]
Secondary outcome measures (6)
- Venous occlusion rate at 90 days [Time frame: 90 days after the first session]
- Final venous occlusion rate at 180 days [Time frame: 180 days after the first session]
- Pain intensity immediately after the procedure [Time frame: Immediately after the procedure (within 30 minutes)]
- Hyperpigmentation at the treated site [Time frame: 30, 90, and 180 days after the first session.]
- Number of treatment sessions required [Time frame: Up to 90 days after the first session.]
- Patient-reported aesthetic satisfaction [Time frame: Assessed at 90 days after the first session.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital Universitário Pedro Ernesto - UERJ — Rio de Janeiro
Identifiers
NCT: NCT07276243 · HUPE-Varizes-Laser-2026