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Completed

NCT Number: NCT04933591

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

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diosmin / Hesperidin

Drug

Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms

Other names: Venoactive drug

Primary outcomes

  1. Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein

    Time frame: 2 months

    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.

Secondary outcomes

  1. Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)

    Time frame: 2 months

    Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered.

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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