Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins (NCT02054325) | Clinical Trial Compass
CompletedPhase 4
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Brazil106 participantsStarted 2012-09
Plain-language summary
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
Who can participate
Age range
18 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* females
* with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg
* clinical classification of chronic venous disease C1(mild venous disease),
* minimum age of 18 year-old and maximum age 69 year-old
* agreement with the study
* signing the free and informed consent ( IC)
* not use anticoagulant drugs .
Exclusion Criteria:
* male
* varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)
* restrict mobility
* arterial insufficiency
* be allergic to any substance that may be related to the study drugs
* any cause of dermatitis on application site
* free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism
* pregnancy
* previous deep vein thrombosis (DVT)
* family history of DVT
* thrombophilia
* do not agree with the search terms
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.
Timeframe: Mean Percent of reticular vein disappearance two months after treatment