Health TrialsbyHealthPanel

Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

ConditionVaricose Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorHospital Universitario Pedro Ernesto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Group A: Foam onlyActive comparator 1 intervention
Group B: Group B: Foam + LaserExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
30 days after the first session

Secondary outcomes

1

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
2

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
3

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.

Time frame
Immediately after the procedure (within 30 minutes)
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario Pedro Ernesto

Lead sponsor

Source ClinicalTrials.gov
Apply now