Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage

Not Applicable

Recruiting

• Conditions: Critical Limb Ischemia; Major Adverse Limb Events; Peripheral Artery Disease; Major Adverse Cardiovascular Events; Hemodynamic Measure

• Registration Number: NCT06318767
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).

It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-04
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• patients at least 18 years old,
• willing and able to provide written informed consent,
• with documented atherosclerosis critical limb ischemia (pain rest and/or ulcer and gangrene manifestations)
• with hemodynamic measures (ankle pressure less than 50mmHg and/or TBI less than 30mmHg and/or TcPO2 less than 30 mmHg),
• followed or send to CHU Amiens Picardie, and eligible to chirurgical revascularization.

Exclusion Criteria

• with non atherosclerosis arteriopathy,
• ineligible to the gold standard treatment such as the chirurgical revascularization,
• with life expectancy less than 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
occurrence of limb ischemia	6 months

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France