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Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins

NCT06367166 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-23

No results posted yet for this study

Summary

The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin).

Conditions

  • Varicose Veins of Lower Limb
  • Varix
  • Vascular Diseases
  • Leg Edema

Interventions

DRUG

"Venarus®" (diosmin and hesperidin)

"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months

PROCEDURE

Endovenous laser ablation (EVLA) with miniphlebectomy

Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.

OTHER

Elastic compression

All subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment

OTHER

Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

The patients and healthy volunteers will undergo evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), Venous clinical severity (VCS) score, Visual Analog Scale (VAS) score and 20 item-ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) at baseline, and 2, 3, and 6 months after enrollment

Sponsors & Collaborators

  • Ryazan State Medical University

    lead OTHER

Principal Investigators

  • Igor Suchkov · RyazSMU

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-04-01
Completion
2026-05-01

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 NCT06367166 on ClinicalTrials.gov