Prospective Cohort Study for Varicose Veins Incidence and Natural Course

N/AActive Not RecruitingNCT04546750

Russian Phlebological Association100 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Varicose Veins of Lower Limb Thromboses, Venous Venous Insufficiency

Eligibility

Sex: ALLMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

"Medalp" private surgery clinic

Saint Petersburg, Sankt-Peterburg, Russia

Outcomes

Primary Outcomes

Incidence of primary varicose veins

Number of Participants with the first identified varicose veins (class C2 according to CEAP classification)

Time frame: 1 year

Secondary Outcomes

Progression of primary varicose veins

The presence of varicose veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)

Time frame: 1 year

Incidence of chronic venous insufficiency

Number of participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)

Time frame: 1 year

Incidence of superficial vein thrombosis

Number of participants with first episode of superficial vein thrombosis

Time frame: 1 year

Incidence of reticular and telangiectatic leg veins

Number of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)

Time frame: 1 year

Progression of reticular and telangiectatic leg veins

The presence of reticular and telangiectatic leg veins in new areas of the lower extremites (each limb is divided into 8 areas: thigh - anterior, posterior, medial, lateral area; lower leg - anterior, posterior, medial, lateral area)

Time frame: 1 year

Data from ClinicalTrials.gov

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