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Active, Not Recruiting

NCT Number: NCT04231942

Elastic Compression Stockings and Varicose Veins Recurrence

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moscow Clinical Hospital name by A.K. Yeramishantsev, Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Graduated Compression Stocking: continuous using

Device

Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings

Graduated Compression Stocking: intermittent using

Device

Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings

Primary outcomes

  1. Number of patients with clinical recurrence of varicose veins on any lower limb

    Time frame: 12 months

    The primary efficacy outcome is the clinical recurrence of varicose veins at 12 months after the treatment, which means the reappearance of the visible or palpable varicose tributaries on any (treated or non-treated) lower limb.

Secondary outcomes

  1. Number of patients with clinical recurrence of varicose veins on treated limb

    Time frame: 12 months

    The reappearance of the visible or palpable varicose tributaries on treated lower limb

  2. Number of patients with ultrasound recurrence of varicose veins on any lower limb

    Time frame: 12 months

    The appearance of invisible and non-palpable VVs on any (treated or non-treated) limb revealed by duplex ultrasound scan (DUS)

  3. Number of patients with ultrasound recurrence of varicose veins on treated limb

    Time frame: 12 months

    The appearance of invisible and non-palpable VVs on treated lower limb revealed by duplex ultrasound scan

  4. Number of patients with recanalization of obliterated great saphenous vein

    Time frame: 12 months

    The venous segment of the previously obliterated great saphenous vein (GSV) with blood flow revealed by DUS and the length of 5 cm and more

  5. Number of patients underwent re-intervention for VVs

    Time frame: 12 months

    Any re-intervention to treat new varicose veins on treated or non-treated lower limb

  6. Number of patients with C0-C1 clinical classes of СVD by CEAP classification

    Time frame: 12 months

    Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification of the chronic venous disease (CVD). Clinical class of C0 - no visible changes; Clinical class of C1- reticular veins and telangiectasia

  7. The value of VCSS on the treated limb

    Time frame: 12 months

    The severity of CVD in the target lower limb is assessed during clinical examination using the updated Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. Maximal score indicates more severe CVD.

  8. The value of CIVIQ-20 score

    Time frame: 12 months

    The quality of life is assessed by the patient independently according to the vein-specific questionnaire Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20). range 0-100, minimal score indicates best quality of life.

  9. Compliance with the use of GCS

    Time frame: 12 months

    Compliance with the use of GCS is assessed based on an analysis of the patient's individual diary. For Group 1 and 2, it is calculated as the ratio of days with a note on the using of GCS to the total number of days when compression is recommended: for Group 1 - the total observation period, for Group 2 - days with indicated activities. For Group 3, compliance is calculated as the total number of days of GCS using to the observation period. Ranges from 0% (no compliance) to 100% (absolute compliance).

  10. Comfort with GCS

    Time frame: 12 months

    Comfort with GCS using is assessed individually by patient by Numeric Rating Scale (NRS). Ranges from 0 (no comfort) to 100% (absolute comfort).

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

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

Acronym: ECOS-VVR

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2020
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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