Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Study Overview
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Brief Summary
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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
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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

Official Title
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Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Conditions
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Varicose Veins of Lower Limb, Thromboses, Venous, Venous Insufficiency

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without Varicose Veins<br>Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) | |
| Patients with Varicose Veins<br>Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of primary varicose veins | Number of Participants with the first identified varicose veins (class C2 according to CEAP classification) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 1 year | 
| Incidence of superficial vein thrombosis | Number of participants with first episode of superficial vein thrombosis | 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) | 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) | 1 year |