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Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry (PETRUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356379
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:
Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects

Condition or disease Intervention/treatment Phase
Popliteal Entrapment Syndrome Diagnostic Test: Transcutaneous oximetry Not Applicable

Detailed Description:
Patients suspected of PES and healthy cpontrols after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of elevation on foot in the standing position.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: transcutaneous oximetry
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients
Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing
 Diagnostic Test: Transcutaneous oximetry
Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves
Sham Comparator: Controls
Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing
 Diagnostic Test: Transcutaneous oximetry
Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves


Outcome Measures
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Primary Outcome Measures :
  1. Presence of a significant DROP decrease [ Time Frame: 1 hour ]
    Comparison of DROP value between PES patients and controls


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls)

Exclusion Criteria:

  • Refuse to participate Exclusion period from another protocole
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356379


Locations
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France
CHU Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Pierre ABRAHAM, MD; PhD University Hospital in Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03356379    
Other Study ID Numbers: 2017-AO1887-46
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
Diagnosis
Peripheral artery disease
sports
Additional relevant MeSH terms:
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Popliteal Artery Entrapment Syndrome
Syndrome
Disease
Pathologic Processes
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases