Actively Recruiting
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Led by Centre Hospitalier le Mans · Updated on 2024-08-29
431
Participants Needed
3
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 and/or 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.
CONDITIONS
Official Title
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Referred to vascular medicine for arterial Doppler ultrasound of at least one lower limb with planned systolic pressure measurement at the toe
- Proven arterial disease, symptomatic or not, defined by either resting ankle systolic pressure index 8) 0.90 or less or resting toe systolic pressure index 0.70 or less
You will not qualify if you...
- Hemodynamic instability preventing delay in treatment for ultrasound and toe pressure measurement
- Scheduled surgical management of the lower limb related to arterial disease at inclusion
- Life expectancy less than 24 hours
- History of transmetatarsal or higher amputation affecting systolic pressure or occlusion measurement at the toe
- Refusal to participate
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Centre Hospitalier de CHOLET
Cholet, France, 49300
Actively Recruiting
2
Centre Hospitalier du Mans
Le Mans, France, 72000
Not Yet Recruiting
3
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
Research Team
C
Christelle JADEAU
CONTACT
J
Jean-Eudes TRIHAN, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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