VEINEX : Venous Investigations During Exercise

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT02689557

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency	Other: plethysmography	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

VEINEX : Venous Investigations During Exercise

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs) [Maximum 3 months]
plethysmographic record for volume measurement of lower limbs at rest, walking and recovery (6 measures stepped on the lower limbs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Angers		France	49933

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator: ANTOINE BRUNEAU, MD, UH ANGERS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT02689557

Other Study ID Numbers:

2014-A01440-47

First Posted:

Feb 24, 2016

Last Update Posted:

Nov 7, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Venous Insufficiency

Study Results

No Results Posted as of Nov 7, 2019