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

Not Applicable

Active, not recruiting

• Conditions: Leg Edema; Vascular Diseases; Varicose Veins of Lower Limb; Varix
• Interventions: Drug: "Venarus®" (diosmin and hesperidin); Other: Elastic compression; Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy; Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

• Registration Number: NCT06367166
• Lead Sponsor: Ryazan State Medical University

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).

Detailed Description

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 Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-10-02
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-14
• Last Update Submitted: 2024-04-14
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2026-04-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
А- Varicose vein patients with Conservative treatment with a venoactive drug	"Venarus®" (diosmin and hesperidin)	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
А- Varicose vein patients with Conservative treatment with a venoactive drug	Elastic compression	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
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	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
B- Varicose veins patients without invasive treatment or a venoactive drug	Elastic compression	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
B- Varicose veins patients without invasive treatment or a venoactive drug	Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores	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
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug	"Venarus®" (diosmin and hesperidin)	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
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug	Endovenous laser ablation (EVLA) with miniphlebectomy	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
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug	Elastic compression	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
C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug	Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores	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
D- Varicose veins patients who will undergo EVLA	Endovenous laser ablation (EVLA) with miniphlebectomy	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
D- Varicose veins patients who will undergo EVLA	Elastic compression	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
D- Varicose veins patients who will undergo EVLA	Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores	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
E-healthy volunteers	Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores	20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment

Primary Outcome Measures

Name	Time	Method
Changes in biomarkers expression in venous wall	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
changes in biomarkers of venous wall remodeling	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

Trial Locations

Locations (1)

RyazanSMU; 🇷🇺 Ryazan, Russian Federation