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Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04546750
Acronym
VINCI
Enrollment
100
Registered
2020-09-14
Start date
2020-09-01
Completion date
2030-09-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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

Interventions

None listed

Sponsors

Russian Phlebological Association
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of primary varicose veins1 yearNumber of Participants with the first identified varicose veins (class C2 according to CEAP classification)

Secondary

MeasureTime frameDescription
Progression of primary varicose veins1 yearThe 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)
Incidence of chronic venous insufficiency1 yearNumber of participants with the first identified sign of chronic venous insufficiency (venous edema, venous eczema, hyperpigmentation of the skin, lipodermatosclerosis, venous ulcer)
Incidence of superficial vein thrombosis1 yearNumber of participants with first episode of superficial vein thrombosis
Incidence of reticular and telangiectatic leg veins1 yearNumber of Participants with the first identified eticular and telangiectatic leg veins ((class C1 according to CEAP classification)
Progression of reticular and telangiectatic leg veins1 yearThe 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)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026