Study Stopped
end of inclusing period
Clinical Interest of the TcPO2 Technique
CINEYSOFT
Multicentric Study of the Clinical Interest of the TcPO2 Technique
1 other identifier
observational
952
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 24, 2022
October 1, 2022
8.9 years
March 7, 2013
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
Patient with buttock pain and referred for an oximetry exercise test
You may qualify if:
- 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
You may not qualify if:
- any heart issues during the last 3 months
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University Hospital
Angers, 49933, 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, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Abraham, MD; PhD
University hospital, Angers, FRANCE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 12, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 24, 2022
Record last verified: 2022-10