Elastic Compression Stockings and Varicose Veins Recurrence (ECOS-VVR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins; Chronic Venous Insufficiency
• Intervention / Treatment: Device: Graduated Compression Stocking: continuous using; Device: Graduated Compression Stocking: intermittent using

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonid Laberko, PhD; Phone Number: +7-903-793-85-74; Email: laberko@list.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Moscow Clinical Hospital name by A.K. Yeramishantsev
    • Contact: Hovsep Manjikyan; Email: manjikyan@yahoo.com
  • Moscow, Russian Federation
    • Recruiting
    • Moscow Clinical Hospital no.24
    • Contact: Ivan Skopintsev; Email: skopintsev_ivan@mail.ru
  • Moscow, Russian Federation
    • Recruiting
    • Moscow private medical clinic "MedSwiss"
    • Contact: Athena Vorontsova, PhD; Email: afina_90_@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1 (experimental): continuous using of GCS; 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; Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
EXPERIMENTAL: Group 2 (experimental): intermittent using of GCS; 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; Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
NO_INTERVENTION: Group 3 (control): no use of GCS; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with clinical recurrence of varicose veins on treated limb	The reappearance of the visible or palpable varicose tributaries on treated lower limb	12 months
Number of patients with ultrasound recurrence of varicose veins on any lower limb	The appearance of invisible and non-palpable VVs on any (treated or non-treated) limb revealed by duplex ultrasound scan (DUS)	12 months
Number of patients with ultrasound recurrence of varicose veins on treated limb	The appearance of invisible and non-palpable VVs on treated lower limb revealed by duplex ultrasound scan	12 months
Number of patients with recanalization of obliterated great saphenous vein	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	12 months
Number of patients underwent re-intervention for VVs	Any re-intervention to treat new varicose veins on treated or non-treated lower limb	12 months
Number of patients with C0-C1 clinical classes of СVD by CEAP classification	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	12 months
The value of VCSS on the treated limb	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.	12 months
The value of CIVIQ-20 score	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.	12 months
Compliance with the use of GCS	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).	12 months
Comfort with GCS	Comfort with GCS using is assessed individually by patient by Numeric Rating Scale (NRS). Ranges from 0 (no comfort) to 100% (absolute comfort).	12 months

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Study Chair: Leonid Laberko, PhD, Pirogov RNRMU; Principal Investigator: Leonid Laberko, PhD, Pirogov RNRMU

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2019
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (ACTUAL): January 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Recurrence; Venous Insufficiency; Varicose Veins
• Other Study ID Numbers: ECOS-VVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No