NCT03356379

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 22, 2017

Last Update Submit

November 29, 2019

Conditions

Popliteal Entrapment Syndrome

Keywords

DiagnosisPeripheral artery diseasesports

Outcome Measures

Primary Outcomes (1)

  • Presence of a significant DROP decrease

    Comparison of DROP value between PES patients and controls

    1 hour

Study Arms (2)

Patients

EXPERIMENTAL

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

Diagnostic Test: Transcutaneous oximetry

Controls

SHAM COMPARATOR

Healthy asymptomatic athletes will have a transcutaneous oximetry test during tiptoeing

Diagnostic Test: Transcutaneous oximetry

Interventions

Transcutaneous oximetryDIAGNOSTIC_TEST

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

ControlsPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Popliteal Artery Entrapment SyndromeDiseasePeripheral Arterial Disease

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

OximetryBlood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Pierre ABRAHAM, MD; PhD

    University Hospital in Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: transcutaneous oximetry
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 29, 2017

Study Start

November 22, 2017

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

FR(1)