Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood

Varicose Veins Clinical Trial

Official title:

Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933591
• Other study ID #: NIS-???-19.03
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 28, 2021

Study information

• Verified date: March 2022
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.

Description:

The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 28, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• • both female and male

• age from 18 to 50 years old

• Verified diagnosis of chronic venous insufficiency CEAP C2-C4

• signed infromed consent

• Absence of any other treatment 2 weeks before the start of the study and throughout the duration of the study

Exclusion Criteria:

• • age less than 18 and more than 50 years

• Previously performed invasive interventions for varicose veins on any of the lower extremities

• No visible varicose veins

• Thrombophlebitis and deep vein thrombosis of the lower extremities in the past

• Taking prohibited pre-trial therapy

• Contraindications to taking Venarus®

• not signed informed consent

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Drug:
• Diosmin / Hesperidin
Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms

Locations

Country	Name	City	State
Russian Federation	Pirogov Russian National Research Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein	Blood samples will be taken from varicose veins and level of cytokine Monocyte Chemoattractant Protein 1 will be measured by immunofluorescence. After 2 months measurement will be repeated and the change will be registered.	2 months
Secondary	Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)	Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered.	2 months