Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT06367166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2023-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004145', 'term': 'Diosmin'}, {'id': 'D006569', 'term': 'Hesperidin'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D005353', 'term': 'Fibronectins'}, {'id': 'D017395', 'term': 'Plasminogen Activator Inhibitor 1'}, {'id': 'D014746', 'term': 'Vimentin'}, {'id': 'D019408', 'term': 'Platelet Endothelial Cell Adhesion Molecule-1'}], 'ancestors': [{'id': 'D047309', 'term': 'Flavones'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D044950', 'term': 'Flavanones'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D015849', 'term': 'Plasminogen Inactivators'}, {'id': 'D015843', 'term': 'Serpins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D007381', 'term': 'Intermediate Filament Proteins'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003598', 'term': 'Cytoskeletal Proteins'}, {'id': 'D015815', 'term': 'Cell Adhesion Molecules'}, {'id': 'D015214', 'term': 'Antigens, Differentiation, Myelomonocytic'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D015415', 'term': 'Biomarkers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2024-04-14', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in biomarkers of venous wall remodeling', 'timeFrame': 'At baseline, and at 2, 3 and 6 months after the start of treatment', 'description': 'Changes in biomarkers of venous wall remodeling including vimentin, fibronectin, PAI-1, vWF, CD31'}, {'measure': 'Changes in biomarkers expression in venous wall', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bioflavonoids', 'venous remodeling', 'varicose veins'], 'conditions': ['Varicose Veins of Lower Limb', 'Varix', 'Vascular Diseases', 'Leg Edema']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nAll subjects in groups A, B, C, and D will receive elastic compression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* the presence of neoplasms, previous operations on the vessels of the lower extremities, deep vein thrombosis, severe concomitant diseases, including infectious ones, pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT06367166', 'briefTitle': 'Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins', 'organization': {'class': 'OTHER', 'fullName': 'Ryazan State Medical University'}, 'officialTitle': 'Study of the Effects of Bioflavonoids on Venous Wall Remodeling in Patients With Varicose Veins of the Lower Extremities', 'orgStudyIdInfo': {'id': 'RyazanSMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'А- Varicose vein patients with Conservative treatment with a venoactive drug', 'description': '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', 'interventionNames': ['Drug: "Venarus®" (diosmin and hesperidin)', 'Other: Elastic compression', 'Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores']}, {'type': 'EXPERIMENTAL', 'label': 'B- Varicose veins patients without invasive treatment or a venoactive drug', 'description': '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', 'interventionNames': ['Other: Elastic compression', 'Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores']}, {'type': 'EXPERIMENTAL', 'label': 'C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug', 'description': '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', 'interventionNames': ['Drug: "Venarus®" (diosmin and hesperidin)', 'Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy', 'Other: Elastic compression', 'Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores']}, {'type': 'EXPERIMENTAL', 'label': 'D- Varicose veins patients who will undergo EVLA', 'description': '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', 'interventionNames': ['Procedure: Endovenous laser ablation (EVLA) with miniphlebectomy', 'Other: Elastic compression', 'Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores']}, {'type': 'EXPERIMENTAL', 'label': 'E-healthy volunteers', 'description': '20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment', 'interventionNames': ['Other: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores']}], 'interventions': [{'name': '"Venarus®" (diosmin and hesperidin)', 'type': 'DRUG', 'otherNames': ['BIOFLAVANOIDS'], 'description': '"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months', 'armGroupLabels': ['C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug', 'А- Varicose vein patients with Conservative treatment with a venoactive drug']}, {'name': 'Endovenous laser ablation (EVLA) with miniphlebectomy', 'type': 'PROCEDURE', 'description': 'Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.', 'armGroupLabels': ['C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug', 'D- Varicose veins patients who will undergo EVLA']}, {'name': 'Elastic compression', 'type': 'OTHER', 'description': 'All subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment', 'armGroupLabels': ['B- Varicose veins patients without invasive treatment or a venoactive drug', 'C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug', 'D- Varicose veins patients who will undergo EVLA', 'А- Varicose vein patients with Conservative treatment with a venoactive drug']}, {'name': 'Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['B- Varicose veins patients without invasive treatment or a venoactive drug', 'C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug', 'D- Varicose veins patients who will undergo EVLA', 'E-healthy volunteers', 'А- Varicose vein patients with Conservative treatment with a venoactive drug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ryazan', 'country': 'Russia', 'facility': 'RyazanSMU', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}], 'overallOfficials': [{'name': 'Igor Suchkov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RyazSMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ryazan State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}