NCT06367166

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ryazan State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-04-16
• Last updated: 2025-07-23

Locations

1 site across 1 country: Russia