Venous InsufficiencyVEINEXNCT02689557
VEINEX : Venous Investigations During Exercise
A study testing plethysmography in people with Venous Insufficiency, run by University Hospital, Angers at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- plethysmography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- present or not venous pathology
Who cannot join
- amputation of a lower limb
- heart failure
- Severe respiratory disease
- Unstable angina or myocardial infarction
- Parkinson's disease, hemiplegia and paraplegia
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Venous Insufficiency
- Being tested
- plethysmography
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Maximum 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ANTOINE BRUNEAU, MD, Principal investigator, UH ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689557
- Sponsor's protocol ID
- 2014-A01440-47
- Acronym
- VEINEX
- Status last verified
- Nov 2019
- First submitted
- 11 Feb 2016
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEINEX : Venous Investigations During Exercise
- ClinicalTrials.gov ID
- NCT02689557
- Acronym / sponsor ID
- VEINEX / 2014-A01440-47
- Conditions
- Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measures of the volumes | Other | Other: plethysmographyMeasures of the volumes of the lower limbs. A measure to rest, a measure of effort (walk) and a measure recovery. Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- present or not venous pathology
Key exclusion criteria (5 listed)
- amputation of a lower limb
- heart failure
- Severe respiratory disease
- Unstable angina or myocardial infarction
- Parkinson's disease, hemiplegia and paraplegia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plethysmographyValidate 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. | Other | measures of the volumes |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANTOINE BRUNEAU, MD principal investigator
UH ANGERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plethysmography in people with Venous Insufficiency, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.