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NCT03900234 Clinical Trial

Prevalence of Chronic Venous Disease in General Population

Chronic Venous Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03900234
Other study ID # 15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2015
Est. completion date August 31, 2015

Study information
Verified date April 2019
Source Pirogov Russian National Research Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 783
Est. completion date August 31, 2015
Est. primary completion date August 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention will be administered
No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.

Locations
Country Name City State
Russian Federation Pirogov Russian National Research Medical University Moscow

Sponsors (1)
Lead Sponsor Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of chronic venous disease 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
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