Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry

NCT ID: NCT03356379

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2019-11-15

Brief Summary

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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

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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.

Conditions

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Popliteal Entrapment Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

transcutaneous oximetry
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients

Patients suspected of PES will have a transcutaneous oximetry test during tiptoeing

Group Type EXPERIMENTAL

Transcutaneous oximetry

Intervention Type DIAGNOSTIC_TEST

Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves

Controls

Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing

Group Type SHAM_COMPARATOR

Transcutaneous oximetry

Intervention Type DIAGNOSTIC_TEST

Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves

Interventions

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Transcutaneous oximetry

Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ABRAHAM, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital in Angers

Locations

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CHU Angers

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2017-AO1887-46

Identifier Type: -

Identifier Source: org_study_id

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