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

Primary Purpose

Varicose Veins, Chronic Venous Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Graduated Compression Stocking: continuous using
Graduated Compression Stocking: intermittent using
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moscow Clinical Hospital name by A.K. YeramishantsevRecruiting
  • Moscow Clinical Hospital no.24Recruiting
  • Moscow private medical clinic "MedSwiss"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group 1 (experimental): continuous using of GCS

Group 2 (experimental): intermittent using of GCS

Group 3 (control): no use of GCS

Arm Description

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;

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;

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)
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
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
Number of patients underwent re-intervention for VVs
Any re-intervention to treat new varicose veins on treated or non-treated lower limb
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
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.
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.
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).
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).

Full Information

First Posted
January 14, 2020
Last Updated
February 21, 2022
Sponsor
Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04231942
Brief Title
Elastic Compression Stockings and Varicose Veins Recurrence
Acronym
ECOS-VVR
Official Title
Elastic Compression Stockings in the Prevention of Varicose Veins Recurrence After Endovenous Thermal Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Chronic Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, open, superiority randomized clinical trial with blinded outcome assessor.
Masking
Outcomes Assessor
Masking Description
Blinded outcome assessor has np information on the patients belonging to the Study Group
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (experimental): continuous using of GCS
Arm Type
Experimental
Arm Description
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;
Arm Title
Group 2 (experimental): intermittent using of GCS
Arm Type
Experimental
Arm Description
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;
Arm Title
Group 3 (control): no use of GCS
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Graduated Compression Stocking: continuous using
Intervention Description
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
Intervention Type
Device
Intervention Name(s)
Graduated Compression Stocking: intermittent using
Intervention Description
Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
Primary Outcome Measure Information:
Title
Number of patients with clinical recurrence of varicose veins on any lower limb
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of patients with clinical recurrence of varicose veins on treated limb
Description
The reappearance of the visible or palpable varicose tributaries on treated lower limb
Time Frame
12 months
Title
Number of patients with ultrasound recurrence of varicose veins on any lower limb
Description
The appearance of invisible and non-palpable VVs on any (treated or non-treated) limb revealed by duplex ultrasound scan (DUS)
Time Frame
12 months
Title
Number of patients with ultrasound recurrence of varicose veins on treated limb
Description
The appearance of invisible and non-palpable VVs on treated lower limb revealed by duplex ultrasound scan
Time Frame
12 months
Title
Number of patients with recanalization of obliterated great saphenous vein
Description
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
Time Frame
12 months
Title
Number of patients underwent re-intervention for VVs
Description
Any re-intervention to treat new varicose veins on treated or non-treated lower limb
Time Frame
12 months
Title
Number of patients with C0-C1 clinical classes of СVD by CEAP classification
Description
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
Time Frame
12 months
Title
The value of VCSS on the treated limb
Description
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.
Time Frame
12 months
Title
The value of CIVIQ-20 score
Description
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.
Time Frame
12 months
Title
Compliance with the use of GCS
Description
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).
Time Frame
12 months
Title
Comfort with GCS
Description
Comfort with GCS using is assessed individually by patient by Numeric Rating Scale (NRS). Ranges from 0 (no comfort) to 100% (absolute comfort).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonid Laberko, PhD
Phone
+7-903-793-85-74
Email
laberko@list.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Kirill Lobastov, PhD
Phone
+7-985-211-63-31
Email
lobastov_kv@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Laberko, PhD
Organizational Affiliation
Pirogov RNRMU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leonid Laberko, PhD
Organizational Affiliation
Pirogov RNRMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Clinical Hospital name by A.K. Yeramishantsev
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hovsep Manjikyan
Email
manjikyan@yahoo.com
Facility Name
Moscow Clinical Hospital no.24
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Skopintsev
Email
skopintsev_ivan@mail.ru
Facility Name
Moscow private medical clinic "MedSwiss"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athena Vorontsova, PhD
Email
afina_90_@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Elastic Compression Stockings and Varicose Veins Recurrence

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