Peripheral Artery DiseasePhase 4NCT01592812
Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device
A Phase 4 study testing electrical muscle stimulation in people with Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- electrical muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French native
- Stable stage 2 peripheral artery disease
- Patent femoral artery on both sides
- Age > 18 years
Who cannot join
- Pregnancy
- Adults protected by maw
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
Stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in PAD patients.
Fifteen adult patients with stable arterial claudication will participate. Recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most symptomatic side.
Read more
The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (NIRS) on both sides.
Patients will be instructed to report eventual contraction-induced pain in the stimulated calf.
Read the detailed description
Investigations are conducted in an air-conditioned 22+/-2 °C room, with the patient comfortably seated on an armchair.
Measured ware started at rest and performed throughout the period pf stimulation and for 10 minutes after the end of the stimulation
Muscle stimulation:
We apply a series of 20 minutes of stimulation with the Veinoplus® device. The device delivers a stimulation of incremental rate with 5 minutes intervals, with 1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz and then stops automatically.
Ultrasound measurements The Diameter of the superficial femoral artery was measured at rest on both sides before each study. The VTI of 3 cardiac cycles (three peaks systolic velocity) will be measured by duplex ultrasound imaging, to calculate the arterial inflow to the leg. Results will be expressed in l /min.
Tcpo2 recording TcpO2 is measured at the chest and on both calves with TCM 400 (Radiometer, DK). Results are expressed in DROP index(mmHg) values.
Near Infra-red spectroscopy (NIRS) We use the ARTinis NIRS device (ARTinis; NL) to estimate tissue saturation (StO2) on both gastrocnemius muscles of the leg.
Systemic hemodynamic parameters
Systemic and diastolic arterial pressures and heart rate are recorded every two minutes using Dinamap V100 (GE france).
- Conditions
- Peripheral Artery Disease
- Being tested
- electrical muscle stimulation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical muscle stimulationDevice
Also called Veinoplus device
Duration of the stimulation 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation | Experimental | Evaluation of the effect of calf stimulation on flow and tissue oxygenation Receives: Device: electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial inflow
Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation
Measured: during stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre Abraham, MD; PhD, Principal investigator, University Hospital in Angers (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592812
- Sponsor's protocol ID
- 2011-A01546-35
- Status last verified
- Mar 2013
- First submitted
- 3 May 2012
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abraham P, Mateus V, Bieuzen F, Ouedraogo N, Cisse F, Leftheriotis G. Calf muscle stimulation with the Veinoplus device results in a significant increase in lower limb inflow without generating limb ischemia or pain in patients with peripheral artery disease. J Vasc Surg. 2013 Mar;57(3):714-9. doi: 10.1016/j.jvs.2012.08.117. Epub 2013 Jan 9.
PubMed 23312939
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
- ClinicalTrials.gov ID
- NCT01592812
- Acronym / sponsor ID
- 2011-A01546-35
- Conditions
- Peripheral Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 May 2012 (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.
Stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in PAD patients.
Fifteen adult patients with stable arterial claudication will participate. Recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most symptomatic side.
The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (NIRS) on both sides.
Patients will be instructed to report eventual contraction-induced pain in the stimulated calf.
Detailed description
Investigations are conducted in an air-conditioned 22+/-2 °C room, with the patient comfortably seated on an armchair.
Measured ware started at rest and performed throughout the period pf stimulation and for 10 minutes after the end of the stimulation
Muscle stimulation:
We apply a series of 20 minutes of stimulation with the Veinoplus® device. The device delivers a stimulation of incremental rate with 5 minutes intervals, with 1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz and then stops automatically.
Ultrasound measurements The Diameter of the superficial femoral artery was measured at rest on both sides before each study. The VTI of 3 cardiac cycles (three peaks systolic velocity) will be measured by duplex ultrasound imaging, to calculate the arterial inflow to the leg. Results will be expressed in l /min.
Tcpo2 recording TcpO2 is measured at the chest and on both calves with TCM 400 (Radiometer, DK). Results are expressed in DROP index(mmHg) values.
Near Infra-red spectroscopy (NIRS) We use the ARTinis NIRS device (ARTinis; NL) to estimate tissue saturation (StO2) on both gastrocnemius muscles of the leg.
Systemic hemodynamic parameters
Systemic and diastolic arterial pressures and heart rate are recorded every two minutes using Dinamap V100 (GE france).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation | Experimental | Device: electrical muscle stimulationEvaluation of the effect of calf stimulation on flow and tissue oxygenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- French native
- Stable stage 2 peripheral artery disease
- Patent femoral artery on both sides
- Age > 18 years
Key exclusion criteria (2 listed)
- Pregnancy
- Adults protected by maw
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 |
|---|---|---|
| electrical muscle stimulationAlso: Veinoplus deviceDuration of the stimulation 20 minutes | Device | electrical stimulation |
Primary outcome
arterial inflow
Time frame: during stimulation
Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation
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 18 Mar 2013.
- Derived from this study: PubMed 23312939Abraham P, Mateus V, Bieuzen F, Ouedraogo N, Cisse F, Leftheriotis G. Calf muscle stimulation with the Veinoplus device results in a significant increase in lower limb inflow without generating limb ischemia or pain in patients with peripheral artery disease. J Vasc Surg. 2013 Mar;57(3):714-9. doi: 10.1016/j.jvs.2012.08.117. Epub 2013 Jan 9.
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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.
Pierre Abraham, MD; PhD principal investigator
University Hospital in Angers (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing electrical muscle stimulation in people with Peripheral Artery Disease, 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 4 inclusion and 2 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 18 Mar 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
arterial inflow (time frame: during stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01592812, which also lists 1 linked publication.
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 18 Mar 2013.