NCT04546750
Recruiting
Not Applicable
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Russian Phlebological Association1 site in 1 country100 target enrollmentSeptember 1, 2020
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins of Lower Limb
- Sponsor
- Russian Phlebological Association
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of primary varicose veins
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course of chronic lower limb vein disease.
Detailed Description
Multicenter prospective cohort observational study based on a termless epidemiological registry. Periodic inspection and collection of data from the subjects is carried out annually, in the last quarter of the current year. Patient data is recorded in a digital database and is constantly updated
Investigators
Eligibility Criteria
Inclusion Criteria
- •A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself
- •The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals
Exclusion Criteria
- •Any invasive treatment of the chronic venous disorder in anamnesis
- •Venous thrombosis in the anamnesis or at the time of inclusion
Outcomes
Primary Outcomes
Incidence of primary varicose veins
Time Frame: 1 year
Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)
Secondary Outcomes
- Incidence of chronic venous insufficiency(1 year)
- Progression of primary varicose veins(1 year)
- Incidence of superficial vein thrombosis(1 year)
- Incidence of reticular and telangiectatic leg veins(1 year)
- Progression of reticular and telangiectatic leg veins(1 year)
Study Sites (1)
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