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NCT06318767 Clinical Trial

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

Peripheral Artery Disease Clinical Trial

— TAMIS  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06318767
Other study ID # PI2023_843_0141
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date September 2025

Study information
Verified date March 2024
Source Centre Hospitalier Universitaire, Amiens
Contact Simon Soudet, Dr
Phone 03 22 88 72 89
Email soudet.simon@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 134
Est. completion date September 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary occurrence of limb ischemia 6 months
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