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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication

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