Clinical Interest of the TcPO2 Technique | NCT01808989

Studies
Clinical Interest of the TcPO2 Technique

NCT01808989

Sponsor

University Hospital, Angers

Status

Terminated

Last Update Posted

Oct 24, 2022Actual

Enrollment

952Actual

Phase

Not provided

Conditions

Claudication

Interventions

Exercise oxymetry

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

end of inclusing period

Expanded Access Info

Start Date

Nov 2013Actual

Primary Completion Date

Oct 2022Actual

Completion Date

Oct 2022Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 7, 2013

First Posted Date

Mar 12, 2013Estimated

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

Oct 20, 2022

Last Update Posted Date

Oct 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

Detailed Description

Pre-test diagnostic hypothesis with probability will be completed by the physician.

Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.

Analysis will be done on differences of pre and post test results.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

952Actual

Name	Type	Description	Arm Group Labels	Other Names
Exercise oxymetry	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test	during a walk on a treadmill, there is a DROP of tcpo2<-15	up to 1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

referred for an oximetry exercise test
Patient able to walk on a treadmill
Patient covered by the French health insurance
Patient able to understand the protocol
Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

any heart issues during the last 3 months
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with buttock pain and referred for an oximetry exercise test

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Abraham, MD; PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Angers		49933	France
University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D007383	Intermittent Claudication
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided