An interventional study of Polidocanol foam sclerotherapy and Transdermal Nd:YAG 1064 nm laser in Varicose Veins, sponsored by Hospital Universitario Pedro Ernesto. Recruiting at 1 site in Brazil. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Hospital Universitario Pedro Ernesto · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Polidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total).
Drug: Polidocanol foam sclerotherapy
Polidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J/cm²), with skin cooling.
Drug: Polidocanol foam sclerotherapy · Device: Transdermal Nd:YAG 1064 nm laser
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
Venous occlusion rate at 30 days
Ultrasound assessment of the treated vein segment 30 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Time frame: 30 days after the first session
Venous occlusion rate at 90 days
Ultrasound assessment of the treated vein segment 90 days after the first session, defined as complete occlusion or partial occlusion with improvement inreflux and/or reduction in venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Time frame: 90 days after the first session
Final venous occlusion rate at 180 days
Ultrasound assessment of the treated vein segment 180 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Time frame: 180 days after the first session
Pain intensity immediately after the procedure
Participant-reported pain intensity in the treated limb, measured immediately after the session, using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
Time frame: Immediately after the procedure (within 30 minutes)
Hyperpigmentation at the treated site
Skin hyperpigmentation will be assessed by an independent physician blinded to the treatment allocation, using standardized comparative photographs obtained at baseline, 30 days, 90 days, and 180 days.
Time frame: 30, 90, and 180 days after the first session.
Number of treatment sessions required
Total number of sessions needed to achieve venous occlusion according to the study protocol (maximum of two sessions).
Time frame: Up to 90 days after the first session.
Patient-reported aesthetic satisfaction
Patient global assessment of cosmetic improvement using a 5-point Likert scale (from "no improvement" to "complete improvement").
Time frame: Assessed at 90 days after the first session.
Plan to share: No — The study will not share individual particiapnt data (IPD). Aggregate results will be published in scientific journals.
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Hospital Universitario Pedro Ernesto