Polidocanol Foam With or Without Transdermal Laser for Varicose Veins: Randomized Clinical Trial

N/ANot Yet RecruitingNCT07276243

Hospital Universitario Pedro Ernesto102 enrolled

Overview

This randomized, double-blind, parallel clinical trial 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Varicose Veins

Interventions

Polidocanol foam sclerotherapyDRUG

Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.

Transdermal Nd:YAG 1064 nm laserDEVICE

Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 samll saphenous vein as long as the saphenous vein is competent on Doppler. * Reflux limited to the target tributary. * Body mass index (BMI) \< 35 km/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).

Locations (1)

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

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 procedura

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 standardizes comparative photographs obtained at baseline, 30 days, 90 days, and 180 days.

Central Contacts

Juliana de Miranda Vieira, PhD

CONTACT

+ 55 21 99972 2885 juliana.vieira@hupe.uerj.br

Data from ClinicalTrials.gov

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