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NCT01808989 Clinical Trial

Clinical Interest of the TcPO2 Technique

Claudication Clinical Trial

— CINEYSOFT  

Official title:
Multicentric Study of the Clinical Interest of the TcPO2 Technique

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01808989
Other study ID # 2013-A00013-42
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2013
Est. completion date October 2022

Study information
Verified date October 2022
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 952
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Exercise oxymetry

Locations
Country Name City State
France University Hospital Angers
France University Hospital Lille
France University Hospital Lomme
France University Hospital Marseille
France University Hospital Nantes
France University Hospital Rennes
France University Hospital Toulouse
France Hospital Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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