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NCT Number: NCT06367166

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RyazanSMU

Ryazan, Russia

About this study

The study will include 80 patients with varicose veins of the lower extremities, CEAP (CEAP classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) clinical class C2s-C3s and 20 healthy volunteers of similar age, gender, and ethnicity (100 patients altogether). The study participants will be divided into five groups: Group A: 20 patients with varicose veins who will be treated conservatively - receive the drug "Venarus®" (diosmin in combination with hesperidin) at a dosage of 1000 mg once daily for 6 months; Group B: 20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with venoactive drugs and will not undergo invasive treatment; Group C: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), followed by Venarus at a dosage of 1000 mg once daily for 6 months; Group D: 20 patients with varicose veins who will undergo invasive treatment (endovenous laser ablation with miniphlebectomy), after which no venoactive drugs will be prescribed. Group E: 20 healthy volunteers without clinical and ultrasound signs of varicose veins.

All subjects in groups A, B, C, and D will receive elastic compression.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study will include men or women over 18 years of age with varicose disease of the lower extremities C2-C3 according to the CEAP classification, confirmed by ultrasound duplex scanning of the veins of the lower extremities

Exclusion criteria

  • the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation

Treatment and study plan

"Venarus®" (diosmin and hesperidin)

Drug

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

Other names: BIOFLAVANOIDS

Endovenous laser ablation (EVLA) with miniphlebectomy

Procedure

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

Elastic compression

Other

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

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

Other

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

Primary outcomes

  1. changes in biomarkers of venous wall remodeling

    Time frame: At baseline, and at 2, 3 and 6 months after the start of treatment

    Changes in biomarkers of venous wall remodeling including vimentin, fibronectin, PAI-1, vWF, CD31

  2. Changes in biomarkers expression in venous wall

    Time frame: 6 months

    Changes in expression of biomarkers of venous wall remodeling (vimentin, fibronectin, PAI-1, vWF, CD31) as assessed with Western blot techniques using the dilated veins harvested during miniphlebectomy

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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