Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Even… (NCT06318767) | Clinical Trial Compass
RecruitingNot 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
France134 participantsStarted 2024-03-07
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring something called 'systolic rise time of the plantar arch' — can you explain what that measurement actually involves and whether it would require any invasive procedures or just non-invasive monitoring for me?
2Since this study is focused on predicting future limb and cardiovascular events in people with critical limb ischemia, would participating in it actually change or delay any treatment I receive, or would it run alongside my standard care?
3The trial is tracking major adverse limb events and major adverse cardiovascular events — given my specific situation, how likely am I to experience these complications, and would this study give my care team any earlier warning signs that could help guide my treatment?
4This appears to be a predictive or observational study rather than a treatment trial — does that mean there's no experimental therapy involved, and if so, what would I personally gain from participating versus just receiving my usual care?
5Given that I have critical limb ischemia, which can progress quickly, is now a good time to consider joining an observational study, or should we focus first on stabilizing my condition with established treatments before exploring research participation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.