Registry for Chronic Venous Disease Incidence and Natural Course
ConditionVaricose Veins of Lower Limb
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorRussian Phlebological Association
About this trial
A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Any invasive treatment of the chronic venous disorder in anamnesis
Venous thrombosis in the anamnesis or at the time of inclusion
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 2 trial groupsGroup A: Patients without Chronic Venous Disease
Group B: Patients with Chronic Veinous Disease
Trial outcomes
Primary outcomes
1
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)
Time frame
1 year2
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
Time frame
1 year3
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 year4
Incidence of superficial vein thrombosis
Number of Participants with the first identified sign of superficial vein thrombosis
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov