Assessing time to predict critical limb ischemia
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
This study is testing a new way to measure blood flow in the legs to see if it can help doctors diagnose critical limb ischemia faster and more accurately for patients with arterial disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 431 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier le Mans Academic / other |
| Locations | 3 sites (Cholet and 2 other locations) |
| Trial ID | NCT06296576 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Critical Limb Ischemia (CLI), a severe stage of arterial disease that requires timely diagnosis for better patient outcomes. It aims to evaluate the systolic rise time of distal arteries using pulsed Doppler flow analysis to improve diagnostic accuracy. Patients aged 18 and older with proven arterial disease will undergo arterial ultrasound scans to measure systolic pressure indices. The study seeks to standardize diagnostic criteria for CLI, which currently vary across different medical societies and countries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with proven arterial disease who are referred for arterial Doppler ultrasound.
Not a fit: Patients with severe haemodynamic instability or those scheduled for immediate surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic protocols for Critical Limb Ischemia, potentially reducing complications and healthcare costs.
How similar studies have performed: Other studies have shown promise in using Doppler flow analysis for diagnosing arterial conditions, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb and for whom a measurement of the systolic pressure index at the toe will be performed. * Presence of proven arterial disease, asymptomatic or not, defined by the presence of one of the following criteria: * Rest ankle systolic pressure index ≤ 0.90 * Rest toe systolic pressure index ≤ 0.70 Exclusion Criteria: * Patient with haemodynamic instability, unable to tolerate a delay in therapeutic management caused by the ultrasound examination and measurement of systolic pressure at the toe; * Patients with surgical management of the lower limb (in relation to lower limb arteriopathy), already scheduled at the time of inclusion. * Patients with a life expectancy of less than 24 hours; * History of transmetatarsal amputation or amputation at a more proximal level compromising the measurement of systolic pressure and occlusion at the toe and/or TCPO2; * Refusal to participate
Where this trial is running
Cholet and 2 other locations
- Centre Hospitalier de CHOLET — Cholet, France (Recruiting)
- Centre Hospitalier du Mans — Le Mans, France (Not_yet_recruiting)
- CHU Poitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Christelle JADEAU
- Email: cjadeau@ch-lemans.fr
- Phone: +33244710781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.