Elastic Compression Stockings and Varicose Veins Recurrence

Last updated: February 21, 2022
Sponsor: Pirogov Russian National Research Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Varicose Veins

Venous Thrombosis

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04231942
ECOS-VVR
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 laserablation (EVLA) or radiofrequency ablation (RFA) - and elimination of varicosetributaries by mini (micro) phlebectomy or sclerotherapy during the 30-45 days beforeenrollment;
  • The technical success of the performed ETA, the absence of reflux in the GSV trunk andthe absence of residual VVs;
  • Lack of signs of chronic venous disease (CVD): clinical class of C0-1 according to theClinical-Etiology-Anatomy-Pathophysiology (CEAP) classification;
  • Lack of vein-specific symptoms - the intensity of any validated vein-specific symptomis less than 30% according to the numeric rating scale (NRS);
  • Signed informed consent.

Exclusion

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 higherby 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.

Study Design

Total Participants: 700
Study Start date:
December 16, 2019
Estimated Completion Date:
December 31, 2025

Study Description

The incidence of new varicose veins (VVs) appearance at 3 years after any invasive treatment is about 20%, and the progression rate of chronic venous disease (CVD) at 2 years after the endovenous thermal ablation (ETA) reaches 40%. When comparing open surgery and endovenous laser ablation (EVLA), the frequency of VVs recurrence at 12 months after intervention does not significantly differ and amounts to 10%. A previous study examining the effect of elastic compression on the risk of VVs recurrence after surgery showed a 92% reduction in relative risk. However, it was limited to the low number of followed patients and the absence of the compliance measurement. Thus, there is still no evidence, if long term using of graduated compression stockings (GSV) after modern modalities of VVs treatment (ETA with mini/micro phlebectomy or sclerotherapy) provides any benefits in the reduction of VVs recurrence. Also, there is no information on what regimen for GCS using is effective to reduce the risk of VVs recurrence: continuous use at every day or intermittent using only during specific activities.

Our hypothesis is that 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.

The aim of the study is to assess the efficacy of regular using of below-knee graduated compression stockings (GCS) of Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) on the risk of varicose veins clinical recurrence after endovenous thermal obliteration of the great saphenous vein and eliminating varicose tributaries in patients without residual varicose veins and / or venous symptoms.

Connect with a study center

  • Moscow Clinical Hospital name by A.K. Yeramishantsev

    Moscow,
    Russian Federation

    Active - Recruiting

  • Moscow Clinical Hospital no.24

    Moscow,
    Russian Federation

    Active - Recruiting

  • Moscow private medical clinic "MedSwiss"

    Moscow,
    Russian Federation

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.