Critical Limb Ischemia and Transcutaneous Oximetry (CITRA)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: 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..

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Pierre ABRAHAM, MD PhD; Phone Number: +33241353689; Email: piabraham@chu-angers.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • University Hospital
    • Contact: Pierre ABRAHAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for critical limb ischemia

Description

Inclusion Criteria:

• Referral for suspected critical limb ischemia

Exclusion Criteria:

• Absence of recording, deny to use medical file

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of TcpO2	Study of TcpO2 variability	1 hour

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Pierre ABRAHAM, MD; PhD, University and univerity hospital in Angers, FRANCE

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: transcutaneous oxygen pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 2019-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data available under reasonable request to the investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No