Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntonio Eduardo Zerati
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Flebogrif
DeviceMechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam.
Polidocanol foam sclerotherapy
DrugPolidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Great saphenous vein insufficiency (1)Active comparator 2 interventions
Group B: Great saphenous vein insufficiency (2)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire
Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire will be used. Score from 0 to 100, where 0 is the best and 100 is the worst quality of life related to varicose veins.
Time frame
From enrollment to the end of treatment at 365 days after procedure2
Disease Severity Score: Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) will be used. Score from 0 to 30, where 0 means asymptomatic patient and 30 means more symptomatic patient as possible.
Time frame
From enrollment to the end of treatment at 365 days after procedure3
Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006
Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006, will be used. Classification where 0 means reflux greater than 1 second, 1 means reflux less than 1 second, and 2 means no reflux.
Time frame
From enrollment to the end of treatment at 365 days after procedureSecondary outcomes
1
Treatment complications
Deep vein thrombosis, thrombophlebitis, visual disturbances, skin irritation and skin hyperpigmentation.
Time frame
One to 365 after procedure2
Pain Level During Procedure: Visual Analog Pain Scale
Visual Analog Pain Scale will be used. Scale where 0 means no pain and 10 means maximum pain during procedure.
Time frame
Pain level during the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Antonio Eduardo Zerati
Lead sponsor
University of Sao Paulo
Sponsor institution
Source ClinicalTrials.gov