Back to resultsPopliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry (PETRUS)
Primary Purpose
Popliteal Entrapment Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcutaneous oximetry
Sponsored by
About this trial
This is an interventional diagnostic trial for Popliteal Entrapment Syndrome focused on measuring Diagnosis, Peripheral artery disease, sports
Eligibility 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
Sites / Locations
- CHU Angers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Patients
Controls
Arm Description
Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing
Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing
Outcomes
Primary Outcome Measures
Presence of a significant DROP decrease
Comparison of DROP value between PES patients and controls
Secondary Outcome Measures
Full Information
NCT ID
NCT03356379
First Posted
November 22, 2017
Last Updated
November 29, 2019
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03356379
Brief Title
Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry
Acronym
PETRUS
Official Title
Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Popliteal Entrapment Syndrome
Keywords
Diagnosis, Peripheral artery disease, sports
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
transcutaneous oximetry
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing
Arm Title
Controls
Arm Type
Sham Comparator
Arm Description
Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing
Intervention Type
Diagnostic Test
Intervention Name(s)
Transcutaneous oximetry
Intervention Description
Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves
Primary Outcome Measure Information:
Title
Presence of a significant DROP decrease
Description
Comparison of DROP value between PES patients and controls
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ABRAHAM, MD; PhD
Organizational Affiliation
University Hospital in Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry
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