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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03568201
Other study ID # 2018 A01046/ 49
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date December 16, 2020

Study information

Verified date August 2020
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 16, 2020
Est. primary completion date December 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Centre hospitalier universitaire Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of a significant DROP decrease Comparison of DROP value between PES patients and controls 1 hour