NCT06296576 Acceleration Time Assessment for Prediction of Critical Limb Ischemia
| NCT ID | NCT06296576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier le Mans |
| Condition | Critical Limb Ischemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 431 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 431 participants in total. It began in 2024-07-01 with a primary completion date of 2026-09-01.
⚠ 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
Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries. Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg). Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery). The main aim of this study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb and for whom a measurement of the systolic pressure index at the toe will be performed. * Presence of proven arterial disease, asymptomatic or not, defined by the presence of one of the following criteria: * Rest ankle systolic pressure index ≤ 0.90 * Rest toe systolic pressure index ≤ 0.70 Exclusion Criteria: * Patient with haemodynamic instability, unable to tolerate a delay in therapeutic management caused by the ultrasound examination and measurement of systolic pressure at the toe; * Patients with surgical management of the lower limb (in relation to lower limb arteriopathy), already scheduled at the time of inclusion. * Patients with a life expectancy of less than 24 hours; * History of transmetatarsal amputation or amputation at a more proximal level compromising the measurement of systolic pressure and occlusion at the toe and/or TCPO2; * Refusal to participate
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06296576 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Limb Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296576 currently recruiting?
Yes, NCT06296576 is actively recruiting participants. Contact the research team at cjadeau@ch-lemans.fr for enrollment information.
Where is the NCT06296576 trial being conducted?
This trial is being conducted at Cholet, France, Le Mans, France, Poitiers, France.
Who is sponsoring the NCT06296576 clinical trial?
NCT06296576 is sponsored by Centre Hospitalier le Mans. The trial plans to enroll 431 participants.