Venous Insufficiency Clinical Trial
— VINCIOfficial title:
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2030 |
Est. primary completion date | September 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | "Medalp" private surgery clinic | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Russian Phlebological Association |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of primary varicose veins | Number of Participants with the first identified varicose veins (class C2 according to CEAP classification) | 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Incidence of superficial vein thrombosis | Number of participants with first episode of superficial vein thrombosis | 1 year | |
Secondary | 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 | |
Secondary | 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 |
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