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Critical Limb Ischemia and Transcutaneous Oximetry (CITRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369781
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Condition or disease Intervention/treatment
Critical Limb Ischemia Diagnostic Test: transcutaneous oxygen pressure recording at rest

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..

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Oximetrie Transcutanee et Ischemie Critique
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Suspected critical limb ischemia
Patients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia
Diagnostic Test: transcutaneous oxygen pressure recording at rest
Recording of limb and chest transcutaneous oxygen pressure




Primary Outcome Measures :
  1. Variability of TcpO2 [ Time Frame: 1 hour ]
    Study of TcpO2 variability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients referred for critical limb ischemia
Criteria

Inclusion Criteria:

  • Referral for suspected critical limb ischemia

Exclusion Criteria:

  • Absence of recording, deny to use medical file

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369781


Contacts
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Contact: Pierre ABRAHAM, MD PhD +33241353689 piabraham@chu-angers.fr

Locations
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France
University Hospital Recruiting
Angers, France
Contact: Pierre ABRAHAM         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Pierre ABRAHAM, MD; PhD University and univerity hospital in Angers, FRANCE
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04369781    
Other Study ID Numbers: 2019-44
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data available under reasonable request to the investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
transcutaneous oxygen pressure
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes