NCT06296576

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 431 (estimated)
• Sponsor: Centre Hospitalier le Mans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

• Critical Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	arterial ultrasound scan	An arterial ultrasound scan of the lower limbs with pulsed Doppler analysis of arterial flow spectra over the abdominal aorta, dorsal artery of the foot and lateral plantar artery, bilaterally

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-03-06
• Last updated: 2024-08-29

Locations

3 sites across 1 country: France