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

NCT04180137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-13

No results posted yet for this study

Summary

Endothelial dysfunction is assessed in patients with chronic venous insufficiency of lower limbs (grade C4 according to C - clinical manifestations, E - etiologic factors, A - anatomic distribution of disease, and P - underlying pathophysiologic findings (CEAP) classification) prior to and after endovenous surgical procedure, i.e. endovenous laser ablation of great saphenous vein, microphlebectomy of varicose branches. Two treatment groups (with and without additional pharmacotherapy) are compared.

Conditions

  • Venous Insufficiency of Leg
  • Venous 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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Yuri M Stoyko, Prof · N.I. Pirogov National Medical and Surgical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2020-12-31
Completion
2021-07-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180137 on ClinicalTrials.gov