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

NCT04180137 | Completed

• 1 other identifier: NMSC-02-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in circulating endothelial cells

  Flow cytometry analysis of circulating cells expressing surface markers: CD 45-, CD 34+, CD 146+, CD 31+, CD 105+ and CD 309+

  baseline and 32 days after surgery

Secondary Outcomes (10)

• Changes in microcirculation

  baseline and 32 days after surgery

• Changes in quality of life

  baseline and 32 days after surgery

• Changes in severity of disease

  baseline and 32 days after surgery

• Changes in homocystein level

  baseline and 32 days after surgery

• Changes in von Willebrand factor level

  baseline and 32 days after surgery

Study Arms (2)

Surgical treatment with subsequent pharmacotherapy

EXPERIMENTAL

Procedure: Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins; Drug: Pharmacotherapy

Isolated surgical treatment

OTHER

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

Interventions

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

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.

Isolated surgical treatment; Surgical treatment with subsequent pharmacotherapy

Pharmacotherapy DRUG

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

Surgical treatment with subsequent pharmacotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-65 years inclusive.
• Diagnosis: varicose veins of lower limbs in the GSV territory.
• Maximum diameter of target vein (GSV) - 15 mm.
• Clinical grade C4 according to CEAP classification.
• Absence of chronic diseases or acute diseases requiring first-line treatment.
• Conditions that limit patient's adherence to study procedures (dementia, neuropsychological disorders, substance and alcohol dependence, etc.).
• Participation in other clinical trials (or administration of investigational medicinal products) within 3 months prior to the study.
• Patient's withdrawal from the study.
• History of thrombosis of superficial and/or deep veins of lower limbs at enrollment into the study.
• Current anticoagulant and phlebotropic therapy.
• Comorbidities requiring first-line treatment.

Sponsors & Collaborators

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

Study Sites (1)

N.I. Pirogov National Medical and Surgical Center

Moscow, 105203, Russia

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yuri M Stoyko, Prof

  N.I. Pirogov National Medical and Surgical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: November 28, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 30, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of the study
• Access Criteria: upon request

Locations

RU (1)