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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03356379
Other study ID # 2017-AO1887-46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2017
Est. completion date November 15, 2019

Study information

Verified date November 2019
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 popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

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 CHU Angers 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