Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2018-01-01
2019-12-31
Brief Summary
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Detailed Description
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For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.
Recordings and patients characteristics are recorded on a institutionally validated database.
A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.
Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Exercise oximetry
Patients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope)
Transcutaneous oxygen pressure measurement during the treadmill test
Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery.
The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest.
Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg.
Interventions
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Transcutaneous oxygen pressure measurement during the treadmill test
Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery.
The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest.
Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Pierre ABRAHAM, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
UH in Angers (FRANCE)
Locations
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University Hospital
Angers, , France
Countries
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Other Identifiers
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2020/42
Identifier Type: -
Identifier Source: org_study_id
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