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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Critical Limb Ischaemia (CLI) is the last stage of arterial disease and requires urgent diagnosis and treatment. This condition's diagnosis varies internationally and is usually based on clinical signs like persistent ischemic pain or necrotic wounds lasting more than two weeks, along with blood flow measurements such as ankle or toe systolic pressures or transcutaneous oxygen pressure. The study aims to validate a reliable and easy-to-use diagnostic tool to screen patients with CLI early and refer them to specialized centers promptly. The study involves performing arterial ultrasound scans of the lower limbs, including pulsed Doppler analysis of blood flow in key arteries such as the abdominal aorta and arteries in the foot. This observational study will assess the diagnostic value of the maximum systolic rise time in the foot arteries over a 12-month period to determine its usefulness in predicting CLI. Participants will be evaluated through arterial Doppler ultrasound scans and measurements of systolic pressure at the toe. The main outcome measured is the diagnostic accuracy of the maximum systolic rise time in distal foot arteries. The study will monitor participants for up to 12 months to assess this measure. Other clinical and hemodynamic data will be collected to support the evaluation and safety monitoring throughout the study duration.
CONDITIONS
Brief 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
- Patient referred to the vascular medicine department for arterial Doppler ultrasound of at least one lower limb
- Measurement of systolic pressure index at the toe will be performed
- Presence of arterial disease defined by rest ankle systolic pressure index 0.90 or less or rest toe systolic pressure index 0.70 or less
You will not qualify if you...
- Haemodynamic instability preventing delay in treatment for ultrasound and pressure measurement
- Scheduled surgical management of the lower limb related to arterial disease at time of inclusion
- Life expectancy less than 24 hours
- History of transmetatarsal or higher level amputation affecting pressure measurement
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo arterial ultrasound scans and measurement of systolic pressure indices to assess arterial disease in the lower limbs.
1 visit (in-person)
Duration - 12 months
Participants are monitored to evaluate the diagnostic performance of arterial measurements over 12 months.
No specific visits required; ongoing observation
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
J
Jean-Eudes TRIHAN, MD
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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