Clinical trial NCT06367166: Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins
Official title: Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Varicose Veins of Lower Limb
Varix
Vascular Diseases
Leg Edema
Keywords: bioflavonoids
venous remodeling
varicose veins
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in biomarkers of venous wall remodeling
timeFrame: At baseline, and at 2, 3 and 6 months after the start of treatment
measure: Changes in biomarkers expression in venous wall
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: RyazanSMU
Study officials:
affiliation: RyazSMU
name: Igor Suchkov
role: PRINCIPAL_INVESTIGATOR
References: