NCT06318767 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
| NCT ID | NCT06318767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Major Adverse Limb Events |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2024-03-07 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06318767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Adverse Limb Events. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06318767 currently recruiting?
Yes, NCT06318767 is actively recruiting participants. Contact the research team at soudet.simon@chu-amiens.fr for enrollment information.
Where is the NCT06318767 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT06318767 clinical trial?
NCT06318767 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 134 participants.