Critical Limb Ischemia and Transcutaneous Oximetry

NCT ID: NCT04369781

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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* 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

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Critical Limb Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Suspected critical limb ischemia

Patients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia

transcutaneous oxygen pressure recording at rest

Intervention Type DIAGNOSTIC_TEST

Recording of limb and chest transcutaneous oxygen pressure

Interventions

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transcutaneous oxygen pressure recording at rest

Recording of limb and chest transcutaneous oxygen pressure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Referral for suspected critical limb ischemia

Exclusion Criteria

* Absence of recording, deny to use medical file
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ABRAHAM, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University and univerity hospital in Angers, FRANCE

Locations

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University Hospital

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre ABRAHAM, MD PhD

Role: CONTACT

+33241353689

Facility Contacts

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Pierre ABRAHAM

Role: primary

Other Identifiers

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2019-44

Identifier Type: -

Identifier Source: org_study_id

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