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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| А- Varicose vein patients with Conservative treatment with a venoactive drug | Experimental | 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 | Experimental | 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 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Venarus®" (diosmin and hesperidin) | Drug | "Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Igor Suchkov | RyazSMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RyazanSMU | Ryazan | Russia |
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Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment
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| Experimental |
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 | Experimental | 20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment |
|
|
| Endovenous laser ablation (EVLA) with miniphlebectomy | Procedure | Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm. |
|
| Elastic compression | Other | 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 | Other | 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 |
|
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| D006569 | Hesperidin |
| D005419 | Flavonoids |
| D005353 | Fibronectins |
| D017395 | Plasminogen Activator Inhibitor 1 |
| D014746 | Vimentin |
| D019408 | Platelet Endothelial Cell Adhesion Molecule-1 |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D044950 | Flavanones |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D015849 | Plasminogen Inactivators |
| D015843 | Serpins |
| D010455 | Peptides |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D001685 | Biological Factors |
| D007381 | Intermediate Filament Proteins |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D003598 | Cytoskeletal Proteins |
| D015815 | Cell Adhesion Molecules |
| D015214 | Antigens, Differentiation, Myelomonocytic |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D015415 | Biomarkers |
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