VEINEX : Venous Investigations During Exercise (VEINEX)

November 5, 2019 updated by: University Hospital, Angers
Successfully develop and confirm with the Higher School of Electronics West Plethysmographic a multichannel recorder to perform measurements staggered volume of the lower limbs at rest, walking and recovery (6 storied measures on members lower).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Validate the measurement made by EAP (Electroactive polymer) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • France
      • Angers, France, 49933
        • University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • present or not venous pathology

Exclusion Criteria:

  • amputation of a lower limb
  • heart failure
  • Severe respiratory disease
  • Unstable angina or myocardial infarction
  • Parkinson's disease, hemiplegia and paraplegia

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: measures of the volumes
Measures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention.
Other: plethysmography
Validate the measurement made by electroactive polymer sensors (plethysmography) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
Time Frame: Maximum 3 months
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
Maximum 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: ANTOINE BRUNEAU, MD, UH Angers

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)

January 1, 2016

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01440-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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