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CompletedNCT03356379PETRUSUpdated Dec 2, 2019

Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry

An interventional study of Transcutaneous oximetry in Popliteal Entrapment Syndrome, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-02.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Popliteal Entrapment Syndrome

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Keywords

  • Diagnosis
  • Peripheral artery disease
  • sports
03

In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age over 18 years
  • Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls)

Exclusion criteria

Exclusion Criteria:

  • Refuse to participate Exclusion period from another protocole
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Patients

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

    Diagnostic Test: Transcutaneous oximetry

  • Sham comparator
    Controls

    Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing

    Diagnostic Test: Transcutaneous oximetry

Interventions

  • Diagnostic testTranscutaneous oximetry

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

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What researchers measure

Primary outcomes

  1. Presence of a significant DROP decrease

    Comparison of DROP value between PES patients and controls

    Time frame: 1 hour

07

Study locations

1 site
  • CHU Angers
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Nov 2019, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2017
First posted
Nov 29, 2017
StartActual
Nov 22, 2017
Primary completionActual
Nov 15, 2019
CompletionActual
Nov 15, 2019
Last update
Dec 2, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03356379
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Nov 22, 2017
Primary completion
Nov 15, 2019
Completion
Nov 15, 2019
Last update
Dec 2, 2019

Study contacts

Pierre ABRAHAM, MD; PhD
principal investigator · University Hospital in Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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