Prospective Cohort Study for Varicose Veins Incidence and Natural Course

NCT ID: NCT04546750

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2030-09-30

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

Conditions

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Varicose Veins of Lower Limb Thromboses, Venous Venous Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients without Varicose Veins

Individuals who do not have varicose veins of lower legs: C0, C1 classes according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)

No interventions assigned to this group

Patients with Varicose Veins

Individuals who have varicose veins of lower legs: C2 Ep class according to Clinical, Etiologic, Anatomic and Pathophysiologic classification (CEAP)

No interventions assigned to this group

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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Russian Phlebological Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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"Medalp" private surgery clinic

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Igor Zolotukhin, MD, PhD

Role: CONTACT

+79255182479

Facility Contacts

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Evgeny Ilyukhin, PhD

Role: primary

Related Links

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https://epid.venousregistry.org/

The accumulation of data will be carried out on the basis of an termless Russian epidemiological registry, ClinicalTrials.gov Identifier: NCT04487314

Other Identifiers

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RPA 7.001.

Identifier Type: -

Identifier Source: org_study_id

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