Peripheral Artery DiseaseCLAUSELNCT02754804
Claudication, Systematic Evaluation of Limp on Treadmill
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. 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?
- Biomechanic parameters
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 12 Mar 2020
- Phase
- Observational
- 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
Study population: Patients complaining claudication and referred for a treadmill test
Who may be able to join
- Referred for treadmill testing
- Age > 18
- Claudication
- Covered by the French Healthcare system
- Consent to participate
Who cannot join
- Unstable angina
- History of lower limb osteo articular rheumatologic disease
- Lower limb amputation
- Cardiac or respiratory failure
- Neurologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Claudication et Fatigue Musculaire de l'artériopathe
Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication
Read the detailed description
Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.
- Conditions
- Peripheral Artery Disease
- Being tested
- Biomechanic parameters
- 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.
Biomechanic parametersDevice
recording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients .
| Study group | Role | What they receive |
|---|---|---|
| PAD patients | Patients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill Receives: Device: Biomechanic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square (RMS) of the electromyogram signal
Calculation for the difference (change) in RMS value at the end vs.beginning of the walking test (RMS is calculated over 15 sec at rest and 15 sec just before the end of the walking period)
Measured: Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 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, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754804
- Sponsor's protocol ID
- 2016-A000052-49
- Acronym
- CLAUSEL
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2016
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claudication et Fatigue Musculaire de l'artériopathe
- ClinicalTrials.gov ID
- NCT02754804
- Acronym / sponsor ID
- CLAUSEL / 2016-A000052-49
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 28 Apr 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.
Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication
Detailed description
Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAD patients | – | Device: Biomechanic parametersPatients with grade 1 claudication Measurement of biomechanic parameters while walking on treadmill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients complaining claudication and referred for a treadmill test
Key inclusion criteria (5 listed)
- Referred for treadmill testing
- Age > 18
- Claudication
- Covered by the French Healthcare system
- Consent to participate
Key exclusion criteria (5 listed)
- Unstable angina
- History of lower limb osteo articular rheumatologic disease
- Lower limb amputation
- Cardiac or respiratory failure
- Neurologic disease
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 |
|---|---|---|
| Biomechanic parametersrecording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients . | Device | PAD patients |
Primary outcome
Root mean square (RMS) of the electromyogram signal
Time frame: Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)
Calculation for the difference (change) in RMS value at the end vs.beginning of the walking test (RMS is calculated over 15 sec at rest and 15 sec just before the end of the walking period)
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 14 Aug 2020.
- 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.
pierre Abraham, MD PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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 14 Aug 2020. 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?
Root mean square (RMS) of the electromyogram signal (time frame: Evaluation is complete immediately at the end of each walking test. (The end of the walking period is the end of participation of each patient, no follow up of patients)). 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 14 Aug 2020.