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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-05-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Varicose Veins of Lower Limb Varix Vascular Diseases Leg Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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А- Varicose vein patients with Conservative treatment with a venoactive drug

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

Group Type EXPERIMENTAL

"Venarus®" (diosmin and hesperidin)

Intervention Type DRUG

"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months

Elastic compression

Intervention Type 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

Intervention Type 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

B- Varicose veins patients without invasive treatment or a venoactive drug

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

Group Type EXPERIMENTAL

Elastic compression

Intervention Type 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

Intervention Type 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

C- Varicose veins patients who will undergo EVLA and conservative treatment with a venoactive drug

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

Group Type EXPERIMENTAL

"Venarus®" (diosmin and hesperidin)

Intervention Type DRUG

"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months

Endovenous laser ablation (EVLA) with miniphlebectomy

Intervention Type PROCEDURE

Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.

Elastic compression

Intervention Type 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

Intervention Type 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

D- Varicose veins patients who will undergo EVLA

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

Group Type EXPERIMENTAL

Endovenous laser ablation (EVLA) with miniphlebectomy

Intervention Type PROCEDURE

Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.

Elastic compression

Intervention Type 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

Intervention Type 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

E-healthy volunteers

20 healthy volunteers without clinical and ultrasound signs of varicose veins receiving no treatment

Group Type EXPERIMENTAL

Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores

Intervention Type 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

Interventions

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"Venarus®" (diosmin and hesperidin)

"Venarus®" (diosmin and hesperidin) at a dosage of 1000 mg once daily for 6 months

Intervention Type DRUG

Endovenous laser ablation (EVLA) with miniphlebectomy

Endovenous laser ablation will be performed under local and tumescent anesthesia, laser wavelength 1470nm.

Intervention Type PROCEDURE

Elastic compression

All subject with varicose veins enrolled in the study will receive class 2 elastic compression (elastic stockings) after enrollment

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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BIOFLAVANOIDS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes