NCT02689557

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

Same day

First QC Date

February 11, 2016

Last Update Submit

November 5, 2019

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

  • 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)

    Maximum 3 months

Study Arms (1)

measures of the volumes

OTHER

Measures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention.

Other: plethysmography

Interventions

plethysmographyOTHER

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.

measures of the volumes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • present or not venous pathology

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • ANTOINE BRUNEAU, MD

    UH ANGERS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 24, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

October 1, 2019

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)