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Systolic Ankle arteriaL Pressure and Transcutaneous oximetrY During a TURTLE Test in Athletes (SALTY-TURTLE)

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ClinicalTrials.gov Identifier: NCT03568201
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : August 14, 2020
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 iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

Condition or disease Intervention/treatment Phase
Iliac Kinking Diagnostic Test: Transcutaneous oximetry Not Applicable

Detailed Description:
Patients suspected of PES and healthy controls after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of thigh flexion in the standing position.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: transcutaneous oximetry
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : April 16, 2021
Estimated Study Completion Date : April 16, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: patients
Patients suspected of iliac kinking will have a transcutaneous oximetry test during hip flexion
 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 hip flexion
 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 affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)

Exclusion Criteria:

  • Refuse to participate Exclusion period from another protocole Non affiliation to the French healthcare system
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): NCT03568201


Contacts
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Contact: pierre Abraham, MD, PhD +33241354093 piabraham@chu-angers.fr

Locations
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France
Centre hospitalier universitaire Recruiting
Angers, France, 49933
Contact: Pierre Abraham, MD, PhD         
Principal Investigator: Pierre Abraham, MD PhD         
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: NCT03568201    
Other Study ID Numbers: 2018 A01046/ 49
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
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