ClaudicationCINEYSOFTNCT01808989
Clinical Interest of the TcPO2 Technique
An observational study of Claudication, run by University Hospital, Angers at 8 sites in France.
Trial summary
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Claudication
- What is being tested?
- Exercise oxymetry
- How many people
- 952 participants
- Where
- 8 sitesFrance
- Study dates
- Nov 2013to Oct 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with buttock pain and referred for an oximetry exercise test
Who may be able to join
- referred for an oximetry exercise test
- Patient able to walk on a treadmill
- Patient covered by the French health insurance
- Patient able to understand the protocol
- Patient agrees to be involve in the protocol and sign the consent form
Who cannot join
- any heart issues during the last 3 months
- pregnancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
University Hospital
Angers, 49933
University Hospital
Lille
University Hospital
Lomme
University Hospital
Marseille
University Hospital
Nantes
University Hospital
Rennes
University Hospital
Toulouse
Hospital
Tours
About this study
Official title: Multicentric Study of the Clinical Interest of the TcPO2 Technique
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.
The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.
Read the detailed description
Pre-test diagnostic hypothesis with probability will be completed by the physician.
Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.
Analysis will be done on differences of pre and post test results.
- Conditions
- Claudication
- Being tested
- Exercise oxymetry
- Keywords
- peripheral artery disease, tcpo2, treadmill walking test, intermittent claudication
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise oxymetryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test
during a walk on a treadmill, there is a DROP of tcpo2<-15
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2022
- Study completionOct 2022
Why it stopped: end of inclusing period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaudicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 952 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
- NCT01808989
- Sponsor's protocol ID
- 2013-A00013-42
- Acronym
- CINEYSOFT
- Status last verified
- Oct 2022
- First submitted
- 7 Mar 2013
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study of the Clinical Interest of the TcPO2 Technique
- ClinicalTrials.gov ID
- NCT01808989
- Acronym / sponsor ID
- CINEYSOFT / 2013-A00013-42
- Conditions
- Claudication
- Keywords
- peripheral artery disease, tcpo2, treadmill walking test, intermittent claudication
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: end of inclusing period
- Enrolment
- 952 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 2013 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 12 Mar 2013 (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.
The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.
The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.
Detailed description
Pre-test diagnostic hypothesis with probability will be completed by the physician.
Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.
Analysis will be done on differences of pre and post test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with buttock pain and referred for an oximetry exercise test
Key inclusion criteria (5 listed)
- referred for an oximetry exercise test
- Patient able to walk on a treadmill
- Patient covered by the French health insurance
- Patient able to understand the protocol
- Patient agrees to be involve in the protocol and sign the consent form
Key exclusion criteria (2 listed)
- any heart issues during the last 3 months
- pregnancy
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 |
|---|---|---|
| Exercise oxymetry | Other | – |
Primary outcome
The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test
Time frame: up to 1 day
during a walk on a treadmill, there is a DROP of tcpo2<-15
Results and safety
The study was stopped early (reason given: end of inclusing period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
Related trials for Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Claudication, run by University Hospital, Angers at 8 sites 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 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: stopped early, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: end of inclusing period). Results are not available in the source record.
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?
The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test (time frame: up to 1 day). 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 24 Oct 2022.