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

NCT06367166 | Active Not Recruiting DMC

• 1 other identifier: RyazanSMU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bioflavonoids; venous remodeling; varicose veins

Outcome Measures

Primary Outcomes (2)

• changes in biomarkers of venous wall remodeling

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

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

• Changes in biomarkers expression in venous wall

  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

  6 months

Study Arms (5)

А- Varicose vein patients with Conservative treatment with a venoactive drug

EXPERIMENTAL

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 along with elastic compression

Drug: "Venarus®" (diosmin and hesperidin); Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

B- Varicose veins patients without invasive treatment or a venoactive drug

EXPERIMENTAL

20 patients with varicose veins C2s-C3s who are not prescribed conservative therapy with a venoactive drug and will not undergo invasive treatment; the patients will receive elastic compression

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

C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug

EXPERIMENTAL

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; the patients will also receive elastic compression

Drug: "Venarus®" (diosmin and hesperidin); Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy; Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

D- Varicose veins patients who will undergo EVLA

EXPERIMENTAL

20 patients with varicose veins patients who will undergo invasive treatment (EVLK with miniphlebectomy), after which no venoactive drugs will be prescribed; the patients will also receive elastic compression

Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy; Other: Elastic compression; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

E-healthy volunteers

EXPERIMENTAL

20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment

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

Interventions

"Venarus®" (diosmin and hesperidin) DRUG

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

Also known as: BIOFLAVANOIDS

C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug; А- Varicose vein patients with Conservative treatment with a venoactive drug

Endovenous laser ablation (EVLA) with miniphlebectomy PROCEDURE

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

C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug; D- Varicose veins patients who will undergo EVLA

Elastic compression OTHER

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

B- Varicose veins patients without invasive treatment or a venoactive drug; C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug; D- Varicose veins patients who will undergo EVLA; А- Varicose vein patients with Conservative treatment with a venoactive drug

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

B- Varicose veins patients without invasive treatment or a venoactive drug; C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug; D- Varicose veins patients who will undergo EVLA; E-healthy volunteers; А- Varicose vein patients with Conservative treatment with a venoactive drug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

RyazanSMU

Ryazan, Russia

Location

MeSH Terms

Conditions

Varicose Veins; Vascular Diseases

Interventions

Diosmin; Hesperidin; Flavonoids; Fibronectins; Plasminogen Activator Inhibitor 1; Vimentin; Platelet Endothelial Cell Adhesion Molecule-1

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Serum Globulins; Globulins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Extracellular Matrix Proteins; Scleroproteins; Plasminogen Inactivators; Serpins; Peptides; Blood Coagulation Factors; Blood Proteins; Biological Factors; Intermediate Filament Proteins; Biopolymers; Polymers; Macromolecular Substances; Cytoskeletal Proteins; Cell Adhesion Molecules; Antigens, Differentiation, Myelomonocytic; Antigens, Differentiation; Antigens, Surface; Antigens; Biomarkers

Study Officials

• Igor Suchkov

  RyazSMU

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: April 16, 2024
• Study Start: April 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

RU (1)