Elastic Compression Stockings and Varicose Veins Recurrence

Varicose Veins Clinical Trial

— ECOS-VVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04231942
• Other study ID #: ECOS-VVR
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2022
• Source: Pirogov Russian National Research Medical University
• Contact: Leonid Laberko, PhD
• Phone: +7-903-793-85-74
• Email: laberko[@]list.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 varicose tributaries.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Recurrence
• Varicose Veins
• Venous Insufficiency

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Moscow Clinical Hospital name by A.K. Yeramishantsev	Moscow
Russian Federation	Moscow Clinical Hospital no.24	Moscow
Russian Federation	Moscow private medical clinic "MedSwiss"	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with C0-C1 clinical classes of ?VD 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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