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A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development 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 promising digital database and is constantly updated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients without Chronic Venous Disease | Individuals who do not have signs of chronic venous diseases of lower legs according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP) | ||
| Patients with Chronic Veinous Disease | Individuals who have signs of chronic venous diseases of lower legs according to CEAP classification (telangiectases, varicose veins, venous edema, skin hyperpigmentation, lipodermatosclerosis, venous ulcer). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Chronic Venous Disease | Number of Participants with the first identified signs of chronic venous disease according to CEAP classification (telangiectasia, varicose veins, edema) | 1 year |
| Natural Course of Chronic Venous Disease | Progression of CVD will be measured as a change in clinical class of CVD according to CEAP classification in every individual affected by CVD | 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 the first identified sign of superficial vein thrombosis | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The main cohort is formed from those who do not have CVD, who are affected by different factors that we register (various physical activities, the presence or absence of pregnancy, etc.).
An additional cohort is formed from those who have CVD at the time of inclusion.
The goal is to track the natural evolution (progression) of the disease, to evaluate the incidence and risk factors of complications.
An extremely important criterion for the formation of the study population is the possibility to control the lower legs veins of observed individuals by a qualified vascular specialist. To date, a qualitative assessment of veins according to the CEAP classification is a weak point in longitudinal epidemiological studies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny Ilyukhin, MD, PhD | Contact | +79218451722 | evgeny@ilyukhin.info |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Medalp" private surgery clinic | Recruiting | Saint Petersburg | Sankt-Peterburg | 197350 | Russia |
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| Label | URL |
|---|---|
| This is a website specially created for this register. | View source |
| The Association of Phlebologists of Russia already has 2 registers, which registered in ClinicalTrials.gov and on the basis of which clinical trials are conducted. | View source |
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