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Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

NCT07276243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-05-05

No results posted yet for this study

Summary

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

  • Varicose Veins

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.

Sponsors & Collaborators

  • Hospital Universitario Pedro Ernesto

    lead OTHER

Principal Investigators

  • Juliana Vieira, PhD · Hospital Universitário Pedro Ernesto - UERJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-24
Primary Completion
2027-08-30
Completion
2027-12-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276243 on ClinicalTrials.gov