Elastic Compression Stockings and Varicose Veins Recurrence (ECOS-VVR)
Varicose Veins, Chronic Venous Insufficiency
About this trial
This is an interventional treatment trial for Varicose Veins
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.
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
Experimental
Experimental
No Intervention
Group 1 (experimental): continuous using of GCS
Group 2 (experimental): intermittent using of GCS
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). 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