Study of Ultrasound Pulse Timing to Detect Critical Limb Ischemia in Adults

What this Trial Is About

Critical Limb Ischaemia CLI is the last stage of arterial disease and requires urgent diagnosis and treatment. This conditions 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.

Acceleration Time Assessment for Prediction of Critical Limb Ischemia