Polidocanol foam with or without transdermal Nd:YAG 1064 nm laser for lower‑leg varicose veins
Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
This trial will test whether adding a transdermal Nd:YAG 1064 nm laser to polidocanol foam sclerotherapy helps close and improve the appearance of lower‑leg varicose veins in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Universitario Pedro Ernesto Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT07276243 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 21–75 years with CEAP clinical class 1–3 lower‑limb tributary varicose veins measuring 2.5–4.0 mm on Doppler, vein depth ≤4 mm, competent saphenous vein, BMI <35, and able to give informed consent.
Not a fit: Patients with CEAP ≥4, axial reflux requiring prior treatment, tributary veins outside the 2.5–4.0 mm or >4 mm depth criteria, pregnancy or breastfeeding, known polidocanol allergy, recent DVT/PE, uninterruptible anticoagulation, or active skin infection are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding the laser could increase early vein closure and improve cosmetic results, potentially reducing the need for repeat treatments.
How similar studies have performed: Foam sclerotherapy and Nd:YAG lasers have shown benefit separately in prior work, but the specific combination of transdermal Nd:YAG with lower‑concentration polidocanol foam is relatively novel and has limited published evidence.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rio de Janeiro, Rio de Janeiro
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.