NCT04231942

Elastic Compression Stockings and Varicose Veins Recurrence

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Varicose Veins
• Chronic Venous Insufficiency

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2019-12-16
• Primary completion: 2027-01-01
• Completion: 2027-12-31
• First posted: 2020-01-18
• Last updated: 2025-06-13

Locations

3 sites across 1 country: Russia