NCT03568201

Brief 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

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 Dec 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

December 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

February 10, 2023

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

June 13, 2018

Last Update Submit

February 9, 2023

Conditions

Iliac Kinking

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 iliac kinking will have a transcutaneous oximetry test during hip flexion

Diagnostic Test: Transcutaneous oximetry

controls

SHAM COMPARATOR

Healthy asymptomatic athletes will have a transcutaneous oximetry test during hip flexion

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 affiliation Symptoms consistent with iliac kinking (patients) or absence of symptoms (controls)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire

Angers, 49933, France

Location

MeSH Terms

Conditions

DiseasePeripheral Arterial Disease

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral 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
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: transcutaneous oximetry
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 26, 2018

Study Start

December 17, 2018

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

February 10, 2023

Record last verified: 2020-08

Locations

FR(1)