Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 28, 2019

Primary Completion Date

December 31, 2020

Study Completion Date

July 30, 2021

Conditions
Venous Insufficiency of LegVenous Insufficiency (Chronic)(Peripheral)Endothelial Dysfunction
Interventions
PROCEDURE

Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins

"Surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol:~The intervention includes treatment of the pathological upright reflux and varicose veins. Ultrasound-guided GSV puncture at the upper third of the leg under local anesthesia. The light guide is inserted into the vein lumen and pushed through to the saphenofemoral junction. Under ultrasound guidance the light guide is positioned at v. epigastrica superficialis junction. Under ultrasound guidance tumescent anesthesia is produced around the GSV from puncture site up to the saphenofemoral junction. Laser coagulation (with radial light guide), linear energy density - 75 J/cm, automatic traction of the light guide at the speed 0.7 mm/sec. Varicose veins are resected through skin punctures using Varady hook 1-2 mm."

DRUG

Pharmacotherapy

After surgical intervention the active treatment group will receive sulodexide 250 lipasemic units (LSU) bid for 30 days.

Trial Locations (1)

105203

N.I. Pirogov National Medical and Surgical Center, Moscow

All Listed Sponsors
lead

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

OTHER

NCT04180137 - Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure | Biotech Hunter | Biotech Hunter