Critical Limb IschemiaCITRANCT04369781
Critical Limb Ischemia and Transcutaneous Oximetry
An observational study of Critical Limb Ischemia, run by University Hospital, Angers at 1 site in France.
Trial summary
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- transcutaneous oxygen pressure recording at rest
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to Oct 2022
- How long will I take part?
- 4 Years
- 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: All patients referred for critical limb ischemia
Who may be able to join
- Referral for suspected critical limb ischemia
Who cannot join
- Absence of recording, deny to use medical file
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oximetrie Transcutanee et Ischemie Critique
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.
Read the detailed description
- Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position.
- Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests.
- TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization.
- We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease.
Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..
- Conditions
- Critical Limb Ischemia
- Being tested
- transcutaneous oxygen pressure recording at rest
- Keywords
- transcutaneous oxygen pressure
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous oxygen pressure recording at restDiagnostic test
Recording of limb and chest transcutaneous oxygen pressure
| Study group | Role | What they receive |
|---|---|---|
| Suspected critical limb ischemia | Patients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia Receives: Diagnostic Test: transcutaneous oxygen pressure recording at rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of TcpO2
Study of TcpO2 variability
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 Oct 2018
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD; PhD, Principal investigator, University and univerity hospital in Angers, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369781
- Sponsor's protocol ID
- 2019-44
- Acronym
- CITRA
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available under reasonable request to the investigator
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oximetrie Transcutanee et Ischemie Critique
- ClinicalTrials.gov ID
- NCT04369781
- Acronym / sponsor ID
- CITRA / 2019-44
- Conditions
- Critical Limb Ischemia
- Keywords
- transcutaneous oxygen pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 30 Apr 2020 (actual)
- 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.
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.
Detailed description
- Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position.
- Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests.
- TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization.
- We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease.
Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected critical limb ischemia | – | Diagnostic Test: transcutaneous oxygen pressure recording at restPatients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred for critical limb ischemia
Key inclusion criteria (1 listed)
- Referral for suspected critical limb ischemia
Key exclusion criteria (1 listed)
- Absence of recording, deny to use medical file
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 |
|---|---|---|
| transcutaneous oxygen pressure recording at restRecording of limb and chest transcutaneous oxygen pressure | Diagnostic test | Suspected critical limb ischemia |
Primary outcome
Variability of TcpO2
Time frame: 1 hour
Study of TcpO2 variability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: Undecided. Data available under reasonable request to the investigator
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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 and univerity 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?
An observational study of Critical Limb Ischemia, 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 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre ABRAHAM, MD PhD (+33241353689, piabraham@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of TcpO2 (time frame: 1 hour). 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 3 Jun 2021.