Leg Edema, Varicose Veins of Lower Limb, Varix, Vascular Diseases
Conditions
Keywords
bioflavonoids, venous remodeling, varicose veins
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.
Interventions
DRUGVenarus® (diosmin and hesperidin)
Venarus® (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months
PROCEDUREEndovenous laser ablation (EVLA) with miniphlebectomy
Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.
OTHERElastic compression
All subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment
OTHEREvaluation 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
Sponsors
Ryazan State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Russia
Outcome results
None listed