Clinical Interest of the TcPO2 Technique

Terminated

• Conditions: Claudication

• Registration Number: NCT01808989
• Lead Sponsor: University Hospital, Angers

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.

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-12
• Study Start: 2013-11
• Status Verified: 2022-10
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 952

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	up to 1 day	during a walk on a treadmill, there is a DROP of tcpo2\<-15

Trial Locations

Locations (2)

Hospital; 🇫🇷 Tours, France

University Hospital; 🇫🇷 Toulouse, France