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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06367166
• Other study ID #: RyazanSMU
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Ryazan State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Russian Federation	RyazanSMU	Ryazan

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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