Varicose Veins
Conditions
Brief 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.
Detailed 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.
Interventions
Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.) | 2 months | Discomfort will be measured by visual-analogue scale. After 2 months measurement will be repeated and the change will be registered. |
Countries
Russia
Outcome results
None listed