Polidocanol Foam With or Without Transdermal Laser in Varicose Veins (FOAM-LASER)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Drug: Polidocanol foam sclerotherapy; Device: Transdermal Nd:YAG 1064 nm laser

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.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana de Miranda Vieira, PhD; Phone Number: + 55 21 99972 2885; Email: juliana.vieira@hupe.uerj.br

Study Locations

• Brazil
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
      • Recruiting
      • Hospital Universitario Pedro Ernesto - UERJ
      • Contact: Juliana de Miranda Vieira, PhD; Phone Number: + 55 21 999722885; Email: juliana.vieira@hupe.uerj.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days after the first session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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").	Assessed at 90 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.	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.	30, 90, and 180 days after the first session.

Collaborators and Investigators

• Sponsor: Hospital Universitario Pedro Ernesto
• Investigators: Principal Investigator: Juliana Vieira, PhD, Hospital Universitario Pedro Ernesto - UERJ

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Equipment and Supplies; Optical Devices; Radiation Equipment and Supplies; Lasers
• Other Study ID Numbers: HUPE-Varizes-Laser-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will not share individual particiapnt data (IPD). Aggregate results will be published in scientific journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No