Elastic Compression Stockings and Varicose Veins Recurrence
Russia319 participantsStarted 2019-12-16
Plain-language summary
Hypothesis. Regular using of Class 1 below-knee graduated compression stockings (RAL GZ 387 standard) compared to the absence of elastic compression will reduce the risk of clinically significant varicose veins recurrence at 12 months after endovenous thermal ablation of the great saphenous vein and elimination of varicose tributaries.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Age over 18 years;
* Varicose veins (VVs) in the system of great saphenous vein (GSV) of one lower limb;
* Performed endovenous thermal ablation (ETA) of the GSV trunk - endovenous laser ablation (EVLA) or radiofrequency ablation (RFA) - and elimination of varicose tributaries by mini (micro) phlebectomy or sclerotherapy during the 30-45 days before enrollment;
* The technical success of the performed ETA, the absence of reflux in the GSV trunk and the absence of residual VVs;
* Lack of signs of chronic venous disease (CVD): clinical class of C0-1 according to the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification;
* Lack of vein-specific symptoms - the intensity of any validated vein-specific symptom is less than 30% according to the numeric rating scale (NRS);
* Signed informed consent.
Exclusion Criteria:
* Bilateral VVs;
* Primary reflux outside the GSV trunk (including combined);
* History of deep or superficial veins thrombosis;
* Verified deep vein reflux;
* Verified non-thrombotic or post-thrombotic venous obstruction;
* Verified pelvic venous insufficiency;
* Persistence of superficial reflux after ETA;
* A tendency for recanalization of previously obliterated veins;
* Persistence of residual VVs - clinical class of C2 by CEAP;
* Persistence of signs of CVD - clinical class of C3 and higher by CEAP;
* Persistence of one or more vein-specific symptom with an intensity of 30% and higher by NRS;
* The need for long-term use of elast…
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
Number of patients with clinical recurrence of varicose veins on any lower limb
Timeframe: 12 months
Trial details
NCT IDNCT04231942
SponsorPirogov Russian National Research Medical University