Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

NCT07276243 | Recruiting

• 1 other identifier: HUPE-Varizes-Laser-2026
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Venous occlusion rate at 90 days

  90 days after the first session

• Final venous occlusion rate at 180 days

  180 days after the first session

• Pain intensity immediately after the procedure

  Immediately after the procedure (within 30 minutes)

• Hyperpigmentation at the treated site

  30, 90, and 180 days after the first session.

• Number of treatment sessions required

  Up to 90 days after the first session.

Study Arms (2)

Group A: Foam only

ACTIVE COMPARATOR

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

Group B: Foam + Laser

EXPERIMENTAL

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

Interventions

Polidocanol foam sclerotherapy DRUG

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

Group A: Foam only; Group B: Foam + Laser

Transdermal Nd:YAG 1064 nm laser DEVICE

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

Group B: Foam + Laser

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

Study Sites (1)

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Interventions

Lasers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Juliana Vieira, PhD

  Hospital Universitário Pedro Ernesto - UERJ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana de Miranda Vieira, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed in a 1:1 ratio using a concealed allocation sequence accessible only at the time of treatment by a staff member not involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: March 24, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)