Critical Limb Ischemia and Transcutaneous Oximetry

• Conditions: Critical Limb Ischemia

• Registration Number: NCT04369781
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Referral for suspected critical limb ischemia

Exclusion Criteria

• Absence of recording, deny to use medical file

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variability of TcpO2	1 hour	Study of TcpO2 variability

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France