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

ConditionsMajor Adverse Limb Events Major Adverse Cardiovascular Events Peripheral Artery Disease Critical Limb Ischemia Hemodynamic Measure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

with non atherosclerosis arteriopathy,

ineligible to the gold standard treatment such as the chirurgical revascularization,

with life expectancy less than 3 months.

Trial design

Design model

Single group

Treatments tested in this trial

hemodynamic measure of the Systolic Time Rise
Other intervention
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

occurrence of limb ischemia

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Source ClinicalTrials.gov

Apply now