Critical Limb Ischemia and Transcutaneous Oximetry | NCT04369781

Studies
Critical Limb Ischemia and Transcutaneous Oximetry

NCT04369781

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jun 3, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Critical Limb Ischemia

Interventions

transcutaneous oxygen pressure recording at rest

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Apr 28, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2021

Last Update Posted Date

Jun 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcutaneous oxygen pressure recording at rest	Diagnostic Test	Recording of limb and chest transcutaneous oxygen pressure	Suspected critical limb ischemia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referral for suspected critical limb ischemia

Exclusion Criteria:

Absence of recording, deny to use medical file

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients referred for critical limb ischemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre ABRAHAM, MD PhD	Contact	+33241353689		piabraham@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Pierre ABRAHAM, MD; PhD	University and univerity hospital in Angers, FRANCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital	Recruiting	Angers			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data available under reasonable request to the investigator

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided