Registry for Chronic Venous Disease Incidence and Natural Course

NCT ID: NCT04487314

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

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-20

Study Completion Date

2050-09-01

Brief Summary

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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.

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 promising digital database and is constantly updated.

Conditions

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Varicose Veins of Lower Limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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).

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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Evgeny Ilyukhin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Evgeny Ilyukhin, MD, PhD

Role: CONTACT

+79218451722

Facility Contacts

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Evgeny Ilyukhin, PhD

Role: primary

Related Links

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https://epid.venousregistry.org/

This is a website specially created for this register.

https://www.venousregistry.org/

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.

Other Identifiers

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RPA 10.001

Identifier Type: -

Identifier Source: org_study_id

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