Clinical Interest of the TcPO2 Technique (CINEYSOFT)

October 20, 2022 updated by: University Hospital, Angers

Multicentric Study of the Clinical Interest of the TcPO2 Technique

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

952

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital
      • Lille, France
        • University Hospital
      • Lomme, France
        • University Hospital
      • Marseille, France
        • University Hospital
      • Nantes, France
        • University Hospital
      • Rennes, France
        • University Hospital
      • Toulouse, France
        • University Hospital
      • Tours, France
        • Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with buttock pain and referred for an oximetry exercise test

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: up to 1 day
during a walk on a treadmill, there is a DROP of tcpo2<-15
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre Abraham, MD; PhD, University hospital, Angers, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 12, 2013

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00013-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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