Back to resultsVEINEX : Venous Investigations During Exercise (VEINEX)
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
plethysmography
Sponsored by
About this trial
This is an interventional diagnostic trial for Venous Insufficiency
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
measures of the volumes
Arm Description
Measures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention.
Outcomes
Primary Outcome Measures
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
Secondary Outcome Measures
Full Information
NCT ID
NCT02689557
First Posted
February 11, 2016
Last Updated
November 5, 2019
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02689557
Brief Title
VEINEX : Venous Investigations During Exercise
Acronym
VEINEX
Official Title
VEINEX : Venous Investigations During Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
measures of the volumes
Arm Type
Other
Arm Description
Measures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention.
Intervention Type
Other
Intervention Name(s)
plethysmography
Intervention Description
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.
Primary Outcome Measure Information:
Title
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANTOINE BRUNEAU, MD
Organizational Affiliation
UH ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VEINEX : Venous Investigations During Exercise
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