About this trial
This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein.
Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments.
Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening.
In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate:
How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.
Eligibility criteria
Qualifiers
CEAP Classification C2, 3 or 4
Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
Disqualifiers
Allergy to sclerosing substances
Deep venous thrombosis, stroke, or pulmonary embolism
Local or generalized infection at the sclerotherapy site
Prolonged immobilization
Trial design
Treatments tested in this trial
- Flebogrif
- Polidocanol foam sclerotherapy
Treatment groups
Sponsors and collaborators
Antonio Eduardo Zerati
Lead sponsor
University of Sao Paulo
Sponsor institution