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NCT Number: NCT07276243

Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, 20551-030, Brazil

Location status: Recruiting

Location contact

Juliana de Miranda Vieira, PhD

CONTACT

[email protected]

+ 55 21 999722885

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Venous occlusion rate at 30 days

    Time frame: 30 days after the first session

    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.

Secondary outcomes

  1. Venous occlusion rate at 90 days

    Time frame: 90 days after the first session

    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.

  2. Final venous occlusion rate at 180 days

    Time frame: 180 days after the first session

    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.

  3. Pain intensity immediately after the procedure

    Time frame: Immediately after the procedure (within 30 minutes)

    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.

  4. Hyperpigmentation at the treated site

    Time frame: 30, 90, and 180 days after the first session.

    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.

  5. Number of treatment sessions required

    Time frame: Up to 90 days after the first session.

    Total number of sessions needed to achieve venous occlusion according to the study protocol (maximum of two sessions).

  6. Patient-reported aesthetic satisfaction

    Time frame: Assessed at 90 days after the first session.

    Patient global assessment of cosmetic improvement using a 5-point Likert scale (from "no improvement" to "complete improvement").

Study contacts

Contact information is provided by the study sponsor or research team.

Juliana de Miranda Vieira, PhD

CONTACT

[email protected]

+ 55 21 99972 2885

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Registry information

Official study title

Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado

Acronym: FOAM-LASER

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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