NCT04369781

Brief Summary

Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 15, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

4 years

First QC Date

April 28, 2020

Last Update Submit

June 2, 2021

Conditions

Critical Limb Ischemia

Keywords

transcutaneous oxygen pressure

Outcome Measures

Primary Outcomes (1)

  • Variability of TcpO2

    Study of TcpO2 variability

    1 hour

Study Arms (1)

Suspected critical limb ischemia

Patients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia

Diagnostic Test: transcutaneous oxygen pressure recording at rest

Interventions

transcutaneous oxygen pressure recording at restDIAGNOSTIC_TEST

Recording of limb and chest transcutaneous oxygen pressure

Suspected critical limb ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred for critical limb ischemia

You may qualify if:

  • Referral for suspected critical limb ischemia

You may not qualify if:

  • Absence of recording, deny to use medical file

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, France

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Pierre ABRAHAM, MD; PhD

    University and univerity hospital in Angers, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre ABRAHAM, MD PhD

CONTACT

+33241353689piabraham@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

April 30, 2020

Study Start

October 15, 2018

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations

FR(1)