Laser boost for varicose vein foam treatment tested in new trial
NCT ID NCT07276243
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a laser to standard foam treatment works better for varicose veins. About 102 adults with small-to-medium leg veins will get either foam alone or foam plus a laser. The main goal is to see if the vein closes up more often after 30 days, with fewer side effects like skin darkening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- polidocanol foam
- What this could lead to
- If successful, this could show that adding a laser to foam treatment improves vein closure and reduces side effects like skin discoloration.
- What could go wrong
- This is a small, early-stage trial with only 102 people. The laser may not provide extra benefit and could increase pain or bruising.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 102 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitário Pedro Ernesto - UERJ
RECRUITINGRio de Janeiro, Rio de Janeiro, 20551-030, Brazil
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