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

N/AActive Not RecruitingNCT06367166

Ryazan State Medical University100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

100

Conditions

Varicose Veins of Lower Limb Varix Vascular Diseases Leg Edema

Interventions

"Venarus®" (diosmin and hesperidin)DRUG

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

Endovenous laser ablation (EVLA) with miniphlebectomyPROCEDURE

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

Elastic compressionOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

RyazanSMU

Ryazan, Russia

Outcomes

Primary Outcomes

changes in biomarkers of venous wall remodeling

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

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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