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
Key facts
- Who runs it
- Centre Hospitalier Universitaire, Amiens
- Where
- Amiens, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 134 people, planned
- Started
- 7 Mar 2024
- Planned end
- Sept 2026
- Type of study
- Interventional
- Treatments tested
- hemodynamic measure of the Systolic Time Rise
- Record updated
- 15 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- with non atherosclerosis arteriopathy,
- ineligible to the gold standard treatment such as the chirurgical revascularization,
- with life expectancy less than 3 months
Where in France
- CHU AmiensAmiens, FranceContact: SOUDET Simon, MDTaking people
About the trial
What the trial wants to find out
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%).
Read full original descriptionShow less
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).
Treatments tested
- hemodynamic measure of the Systolic Time Rise
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 June 2026