Using compression stockings to prevent varicose veins recurrence

Elastic Compression Stockings in the Prevention of Varicose Veins Recurrence After Endovenous Thermal Ablation

This study is testing if wearing special compression stockings can help prevent varicose veins from coming back after treatment in people who have had endovenous thermal ablation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pirogov Russian National Research Medical University (other)
• Locations: 3 sites (Moscow and 2 other locations)
• Trial ID: NCT04231942 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Class 1 below-knee graduated compression stockings in reducing the recurrence of varicose veins after endovenous thermal ablation. Participants will be divided into groups using the stockings continuously or intermittently, compared to a control group without compression. The study aims to determine if regular use of these stockings can significantly lower the risk of new varicose veins developing within 12 months post-treatment. The research addresses a gap in evidence regarding the long-term benefits of compression therapy following modern varicose vein treatments.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have undergone endovenous thermal ablation for varicose veins in one lower limb and have no signs of chronic venous disease.

Not a fit: Patients with bilateral varicose veins or a history of deep or superficial vein thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to significantly reduce the recurrence of varicose veins in patients after treatment.

How similar studies have performed: Previous studies have shown promising results regarding the use of compression stockings, but this specific approach has not been extensively tested.

Eligibility criteria

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 elastic compression;
* Contraindications or restrictions for the long-term use of GCS;
* The need for long-term use of vein-active drugs (more than 1 month);
* Refusal to participate in the study.

Where this trial is running

Moscow and 2 other locations

• Moscow Clinical Hospital name by A.K. Yeramishantsev — Moscow, Russian Federation (RECRUITING)
• Moscow Clinical Hospital no.24 — Moscow, Russian Federation (RECRUITING)
• Moscow private medical clinic "MedSwiss" — Moscow, Russian Federation (RECRUITING)

Study contacts

• Principal investigator: Leonid Laberko, PhD — Pirogov RNRMU
• Study coordinator: Leonid Laberko, PhD

Conditions: Varicose Veins, Chronic Venous Insufficiency