Assessing the Systolic Rise Time's ability to predict limb and cardiovascular events in severe peripheral artery disease
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
Run by Centre Hospitalier Universitaire, Amiens · NCT06318767 · Data updated 2026-11-12
This study is testing if a specific measurement from the foot can help predict serious problems with limbs and heart health in people with severe peripheral artery disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 134 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | March 7, 2024 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06318767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with documented atherosclerosis critical limb ischemia and specific hemodynamic measures.
✕Probably not a fit
Patients with non-atherosclerotic arteriopathy or those ineligible for surgical revascularization may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the prognostic value of the Systolic Rise Time (SRT) of the plantar arch in patients with critical limb ischemia due to peripheral artery disease (PAD). It aims to determine how well this hemodynamic measure can predict major adverse limb events (MALE) and major adverse cardiovascular events (MACE). By monitoring SRT, the study seeks to provide a reliable marker for assessing the risk of progression in PAD and associated cardiovascular complications. The research will involve patients who meet specific criteria related to their condition and hemodynamic measurements.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients with critical limb ischemia, potentially reducing adverse events.
How similar studies have gone: While the Systolic Rise Time is a relatively new measure, similar hemodynamic assessments have shown promise in predicting outcomes in vascular diseases.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Simon Soudet, Dr
- Email: soudet.simon@chu-amiens.fr
- Phone: 03 22 88 72 89
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.