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

NCT ID: NCT07276243

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-30

Brief Summary

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.

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A: Foam only

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).

Group Type: ACTIVE_COMPARATOR

Polidocanol foam sclerotherapy

Intervention Type: DRUG

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

Group B: Foam + Laser

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.

Group Type: EXPERIMENTAL

Transdermal Nd:YAG 1064 nm laser

Intervention Type: DEVICE

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

Polidocanol foam sclerotherapy

Intervention Type: DRUG

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

Interventions

Transdermal Nd:YAG 1064 nm laser

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

Intervention Type: DEVICE

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.

Intervention Type: DRUG

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 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role: lead

Responsible Party

Juliana de Miranda Vieira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana Vieira, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário Pedro Ernesto - UERJ

Locations

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Central Contacts

Juliana de Miranda Vieira, PhD

Role: CONTACT

juliana.vieira@hupe.uerj.br

+ 55 21 99972 2885

Facility Contacts

Juliana de Miranda Vieira, PhD

Role: primary

juliana.vieira@hupe.uerj.br

+ 55 21 999722885

Other Identifiers

HUPE-Varizes-Laser-2026

Identifier Type: -

Identifier Source: org_study_id