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Clinical Interest of the TcPO2 Technique

Multicentric Study of the Clinical Interest of the TcPO2 Technique

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01808989
Acronym
CINEYSOFT
Enrollment
952
Registered
2013-03-12
Start date
2013-11-30
Completion date
2022-10-31
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication

Keywords

peripheral artery disease, tcpo2, treadmill walking test, intermittent claudication

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.

Interventions

OTHERExercise oxymetry

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 testup to 1 dayduring a walk on a treadmill, there is a DROP of tcpo2\<-15

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026