Elastic Compression Stockings and Varicose Veins Recurrence

NCT04231942 | Active Not Recruiting DMC

• 1 other identifier: ECOS-VVR
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Varicose Veins; Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (10)

• Number of patients with clinical recurrence of varicose veins on treated limb

  12 months

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

  12 months

• Number of patients with ultrasound recurrence of varicose veins on treated limb

  12 months

• Number of patients with recanalization of obliterated great saphenous vein

  12 months

• Number of patients underwent re-intervention for VVs

  12 months

Study Arms (3)

Group 1 (experimental): continuous using of GCS

EXPERIMENTAL

At 30-45 days after the intervention for VVs treatment patients without objective signs (C0-1) and subjective symptoms (intensity of 30% and less) of CVD, without any need for long-term using of GCS and/or vein-active drugs will receive appropriate recommendations on lifestyle correction (avoiding long static activities, maintaining an active lifestyle, the correction of excess weight and constipation, a diet with enough fiber and vitamins) and physical activity (visiting the pool, exercises that improve venous outflow). In addition to lifestyle correction and exercises, patients will be recommended to use Class 1 (RAL GZ 387) below-knee GCS (at least 8 hours per day) for both lower extremities every day for 12 months, while change of GCS for the new one should be carried out at 6 months or early in case of stocking deterioration;

Device: Graduated Compression Stocking: continuous using

Group 2 (experimental): intermittent using of GCS

EXPERIMENTAL

At 30-45 days after the intervention for VVs treatment patients without objective signs (C0-1) and subjective symptoms (intensity of 30% and less) of CVD, without any need for long-term using of GCS and/or vein-active drugs will receive appropriate recommendations on lifestyle correction (avoiding long static activities, maintaining an active lifestyle, the correction of excess weight and constipation, a diet with enough fiber and vitamins) and physical activity (visiting the pool, exercises that improve venous outflow). In addition to lifestyle correction and exercises, patients will be recommended to use Class 1 (RAL GZ 387) below-knee GCS on both limbs during physical activity and long stasis events: any kind of sport activities, air travel of any duration, traveling on vehicles for more than 4 hours, walking for more than 2 hours, standing work for more than 4 hours) for 12 months, while change of GCS for the new one should be carried in case of stocking deterioration;

Device: Graduated Compression Stocking: intermittent using

Group 3 (control): no use of GCS

NO INTERVENTION

At 30-45 days after the intervention for VVs treatment patients without objective signs (C0-1) and subjective symptoms (intensity of 30% and less) of CVD, without any need for long-term using of GCS and/or vein-active drugs will receive appropriate recommendations on lifestyle correction (avoiding long static activities, maintaining an active lifestyle, the correction of excess weight and constipation, a diet with enough fiber and vitamins) and physical activity (visiting the pool, exercises that improve venous outflow). The use of GCS will be possible "on-demand" when symptoms or risk factors appear after appropriate coordination with the Investigator

Interventions

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

Group 1 (experimental): continuous using of GCS

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

Group 2 (experimental): intermittent using of GCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (3)

Moscow Clinical Hospital name by A.K. Yeramishantsev

Moscow, Russia

Location

Moscow Clinical Hospital no.24

Moscow, Russia

Location

Moscow private medical clinic "MedSwiss"

Moscow, Russia

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leonid Laberko, PhD

  Pirogov RNRMU

  STUDY CHAIR

• Leonid Laberko, PhD

  Pirogov RNRMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded outcome assessor has np information on the patients belonging to the Study Group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, open, superiority randomized clinical trial with blinded outcome assessor.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: December 16, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)