Status:
RECRUITING
Acceleration Time Assessment for Prediction of Critical Limb Ischemia
Lead Sponsor:
Centre Hospitalier le Mans
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
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 conditio...
Eligibility 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT06296576
Start Date
July 1 2024
End Date
September 1 2026
Last Update
August 29 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier de CHOLET
Cholet, France, 49300
2
Centre Hospitalier du Mans
Le Mans, France, 72000
3
CHU Poitiers
Poitiers, France, 86000