Major Adverse Limb EventsTAMISNCT06318767
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
A study testing hemodynamic measure of the Systolic Time Rise in people with Major Adverse Limb Events and Major Adverse Cardiovascular Events, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease
- What is being tested?
- hemodynamic measure of the Systolic Time Rise
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- with non atherosclerosis arteriopathy,
- ineligible to the gold standard treatment such as the chirurgical revascularization,
- with life expectancy less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
SOUDET Simon, MD, 03 22 88 72 89, soudet.simon@chu-amiens.fr
About this study
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).
- Conditions
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease, Critical Limb Ischemia, Hemodynamic Measure
- Being tested
- hemodynamic measure of the Systolic Time Rise
- Keywords
- major adverse limb events, major adverse cardiovascular events, peripheral artery disease, critical limb ischemia, hemodynamic measure
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic measure of the Systolic Time RiseOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of limb ischemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start7 Mar 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Limb EventsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318767
- Sponsor's protocol ID
- PI2023_843_0141
- Acronym
- TAMIS
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06318767
- Acronym / sponsor ID
- TAMIS / PI2023_843_0141
- Conditions
- Major Adverse Limb Events, Major Adverse Cardiovascular Events, Peripheral Artery Disease, Critical Limb Ischemia, Hemodynamic Measure
- Keywords
- major adverse limb events, major adverse cardiovascular events, peripheral artery disease, critical limb ischemia, hemodynamic measure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- with non atherosclerosis arteriopathy,
- ineligible to the gold standard treatment such as the chirurgical revascularization,
- with life expectancy less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodynamic measure of the Systolic Time RiseThe 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. | Other | – |
Primary outcome
occurrence of limb ischemia
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemodynamic measure of the Systolic Time Rise in people with Major Adverse Limb Events and Major Adverse Cardiovascular Events, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Soudet, Dr (03 22 88 72 89, soudet.simon@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of limb ischemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.