Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296576
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Brief Title:
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Sponsor:
Centre Hospitalier le Mans
Organization:
Centre Hospitalier le Mans
Study Overview
Official Title:
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATACLI
Brief Summary:
Critical Limb Ischaemia CLI the final stage of arterial disease is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it The growing prevalence of this condition and the associated healthcare costs make it an important public health objective Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries
Its diagnosis is most frequently based on the combination of a clinical criterion ischaemic decubitus pain andor necrotic wounds with a time to onset 2 weeks and a haemodynamic criterion ankle systolic pressure ASP 50mmHg or toe systolic pressure TSP 30 mmHg or transcutaneous oxygen pressure TCPO2 30 mmHg
Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries dorsal artery of the foot and lateral plantar artery
The main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible
Its diagnosis is most frequently based on the combination of a clinical criterion ischaemic decubitus pain andor necrotic wounds with a time to onset 2 weeks and a haemodynamic criterion ankle systolic pressure ASP 50mmHg or toe systolic pressure TSP 30 mmHg or transcutaneous oxygen pressure TCPO2 30 mmHg
Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries dorsal artery of the foot and lateral plantar artery
The main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None