Prevalence of Chronic Venous Disease in General Population

April 1, 2019 updated by: Igor Zolotukhin, Pirogov Russian National Research Medical University

Cross-Sectional Population Based Study on Prevalence and Risk Factors for Chronic Venous Disease in General Population

This study is designed to find prevalence and risk factors for chronic venous disease (CVD) in the general population. All the resident, who live in a single rural settlement will be invited to participate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has cross-sectional design. All the residents aged 10 and more, living in the single rural settlement located in Central Russia will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Possible factors that may influence CVD development will be registered.

Signs and symptoms of CVD will be registered. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Study Type

Observational

Enrollment (Actual)

783

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Pirogov Russian National Research Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the residents of 10 years and more living in the same settlement, willing to participate will be included

Description

Inclusion Criteria:

  • residents living in the rural settlement where study will be conducted
  • both female and male
  • age 10 years and more
  • agree to participate
  • signed infromed consent

Exclusion Criteria:

  • age 9 years and less
  • not signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Residents of the single rural settlement
No interventions will be administered
Other: No intervention will be administered
No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of chronic venous disease
Time Frame: up to Sept. 2015
As a disease positive subjects with any morphological and functional abnormalities of the venous system of long duration manifested either by symptoms and/or signs indicating the need for investigation and/or care will be considered
up to Sept. 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Investigators

  • Principal Investigator: Igor Zolotukhin, Prof, Russian National Research Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

August 31, 2015

Study Completion (ACTUAL)

August 31, 2015

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (ACTUAL)

April 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD are going to be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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