Foam Sclerotherapy With or Without Transdermal Laser for Small Veins in the Legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, intraindividual, split-leg trial comparing two treatments for small leg veins in women with bilateral CEAP C1 telangiectasias and/or reticular veins. One leg receives Cryo-Laser After Foam (CLaF) treatment, which combines polidocanol foam sclerotherapy with immediate transdermal 1064 nm Nd:YAG laser and cold-air cooling, while the other leg receives isolated foam sclerotherapy. Outcomes include vascular clearance, residual vascular area, hyperpigmentation, thrombi retention, need for drainage, pain, adverse events, aesthetic improvement, patient satisfaction, and quality of life up to 180 days. The study aims to determine if the combination approach offers advantages over foam alone. All participants are adult women aged 18-60 with bilateral, symmetrical C1 venous disease of the lower limbs and no major exclusion criteria identified.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female participants aged 18 to 60 years.
* Fitzpatrick skin phototype I, II, or III.
* CEAP clinical class C1.
* Bilateral relatively symmetrical presence of telangiectasias and reticular veins on the lateral thigh.
* Presence of telangiectasias and reticular veins measuring 0.1 to 3 mm in diameter.
* Body mass index (BMI) ≤ 30 kg/m²
* Willingness to participate in the complete study follow-up and provision of written informed consent.

Exclusion Criteria:

* Saphenous or perforator venous reflux.
* Varicose veins greater than 3 mm in diameter (CEAP C2-C6).
* Fitzpatrick skin phototype IV, V, or VI.
* Recent venous thrombosis or known thrombophilia.
* Use of anticoagulant therapy.
* Pregnancy or breastfeeding.
* Known allergy to polidocanol.
* Peripheral arterial disease with ankle-brachial index (ABI) \< 0.8.
* Diabetes mellitus.
* Local dermatitis in the treatment area.
* Previous venous treatment within the last 6 months.
* Failure to attend the treatment session or scheduled follow-up visits.

Where it's running

• Clínica Civil - FAEPA USP
  Ribeirão Preto, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Cecília S Ulacia, MD — University of Sao Paulo
• Study coordinator: Cecília S Ulacia, MD
• Email: ceciliasalazarulacia@usp.br
• Phone: +55 (16) 3963-6500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nd:YAG Laser Plus Sclerotherapy vs Diode Laser Plus Sclerotherapy for Spider Veins and Reticular Veins

  This study tests whether Nd:YAG laser combined with injection sclerotherapy clears reticular veins and spider veins better than a diode laser combined with injection sclerotherapy using the Cryo-Laser and Cryo-Sclerotherapy (CLaCS) approach.

  Recruiting Ain Shams University · Cairo · NCT07678697

• Ruscus for symptom control in uncomplicated chronic venous disease

  This real-world study follows adults with symptomatic chronic venous disease who are taking Ruscus aculeatus as part of normal care to see how it affects symptoms, quality of life, and safety over 90 days.

  Recruiting at 20 sites Turkish Society for Vascular and Endovascular Surgery · Ankara, Ankara and 24 other locations · NCT07737236

• Photobiomodulation plus compression for venous leg ulcers

  This trial tests whether adding photobiomodulation to standard compression therapy helps healing venous leg ulcers.

  Recruiting University of Nove de Julho · Lençóis Paulista, São Paulo · NCT07123285

• Comparing laser treatment and sclerotherapy for reticular leg veins

  This study is testing whether a new laser treatment for reticular leg veins works as well as the traditional sclerotherapy, and it will also look at how patients feel about each option and any side effects they might have.

  Recruiting Derzhavin Tambov State University · Tambov · NCT06175754

• Reducing skin tone inequities in chronic venous insufficiency care

  This project will try ways to recognize and document leg skin changes in people with darker skin tones who have chronic venous insufficiency.

  Recruiting King's College London · London, London and 1 other locations · NCT06798766

• Pedal Pump for leg edema in hospitalized patients

  A device-based test to see if a 10-minute Pedal Pump treatment can help reduce leg swelling in hospitalized patients with edema due to conditions like heart failure or venous problems.

  Recruiting Hillcrest · Tulsa, Oklahoma · NCT07809516

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.