Varicose VeinsECOS-VVRNCT04231942

Elastic Compression Stockings and Varicose Veins Recurrence

A study testing Graduated Compression Stocking: continuous using and Graduated Compression Stocking: intermittent using in people with Varicose Veins and Chronic Venous Insufficiency, run by Pirogov Russian National Research Medical University at 3 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Varicose Veins, Chronic Venous Insufficiency
What is being tested?: Graduated Compression Stocking: continuous using and Graduated Compression Stocking: intermittent using
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 319 participants
Where: 3 sitesRussia
Study dates: 16 Dec 2019to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

Moscow Clinical Hospital name by A.K. Yeramishantsev
Moscow
Moscow Clinical Hospital no.24
Moscow
Moscow private medical clinic "MedSwiss"
Moscow

Other trials in Russia

About this study

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

Read the 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.

Conditions: Varicose Veins, Chronic Venous Insufficiency
Being tested: Graduated Compression Stocking: continuous using, Graduated Compression Stocking: intermittent using
Medical subject headings: Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Graduated Compression Stocking: continuous usingDevice
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
Graduated Compression Stocking: intermittent usingDevice
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings

Study groups in NCT04231942
Study group	Role	What they receive
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; Receives: 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; Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (10)

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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201931 Dec 2027

First posted18 Jan 2020
Study start16 Dec 2019
Primary completion1 Jan 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Varicose VeinsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A multicenter, open, superiority randomized clinical trial with blinded outcome assessor.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 319 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04231942
Sponsor's protocol ID: ECOS-VVR
Acronym: ECOS-VVR
Status last verified: May 2025
First submitted: 14 Jan 2020
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Elastic Compression Stockings in the Prevention of Varicose Veins Recurrence After Endovenous Thermal Ablation
ClinicalTrials.gov ID: NCT04231942
Acronym / sponsor ID: ECOS-VVR / ECOS-VVR
Conditions: Varicose Veins, Chronic Venous Insufficiency
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 319 participants (actual)
Lead sponsor: Pirogov Russian National Research Medical UniversityUniversity, hospital or other
Study start: 16 Dec 2019 (actual)
Primary completion: 1 Jan 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 18 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: A multicenter, open, superiority randomized clinical trial with blinded outcome assessor.

Arm	Type	Receives
Group 1 (experimental): continuous using of GCS	Experimental	Device: Graduated Compression Stocking: continuous usingAt 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;
Group 2 (experimental): intermittent using of GCS	Experimental	Device: Graduated Compression Stocking: intermittent usingAt 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;
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Graduated Compression Stocking: continuous usingClass 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings	Device	Group 1 (experimental): continuous using of GCS
Graduated Compression Stocking: intermittent usingClass 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings	Device	Group 2 (experimental): intermittent using of GCS

Primary outcome

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.

10 secondary outcomes

Number of patients with clinical recurrence of varicose veins on treated limb
Time frame: 12 months
Number of patients with ultrasound recurrence of varicose veins on any lower limb
Time frame: 12 months
Number of patients with ultrasound recurrence of varicose veins on treated limb
Time frame: 12 months
Number of patients with recanalization of obliterated great saphenous vein
Time frame: 12 months
Number of patients underwent re-intervention for VVs
Time frame: 12 months
Number of patients with C0-C1 clinical classes of СVD by CEAP classification
Time frame: 12 months
The value of VCSS on the treated limb
Time frame: 12 months
The value of CIVIQ-20 score
Time frame: 12 months
Compliance with the use of GCS
Time frame: 12 months
Comfort with GCS
Time frame: 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leonid Laberko, PhD study chair

Pirogov RNRMU

Leonid Laberko, PhD principal investigator

Pirogov RNRMU

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with clinical recurrence of varicose veins on any lower limb (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04231942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.