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Clinical Trials in France / NCT06318767
Recruiting Not applicable

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

NCT06318767 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2024-03-07
Last updated
2026-06-15

Condition(s) studied

Major Adverse Limb EventsMajor Adverse Cardiovascular EventsPeripheral Artery DiseaseCritical Limb IschemiaHemodynamic Measure

Investigational drug(s) / intervention(s)

hemodynamic measure of the Systolic Time Rise

hemodynamic measure of the Systolic Time Rise: The hemodynamic measure of the Systolic Time Rise will be added in the routine doppler echography, planned in preoperative, postoperative and at 6 months of following up. This measure is taken on the foot, with ultrasound probe.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06318767 on ClinicalTrials.gov ↗ ← All trials in France