Status:

RECRUITING

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

Lead Sponsor:

Centre Hospitalier le Mans

Conditions:

Critical Limb Ischemia

Eligibility:

All Genders

18+ years

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 conditio...

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

Key Trial Info

Start Date :

July 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

431 Patients enrolled

Trial Details

Trial ID

NCT06296576

Start Date

July 1 2024

End Date

September 1 2026

Last Update

August 29 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Centre Hospitalier de CHOLET

Cholet, France, 49300

2

Centre Hospitalier du Mans

Le Mans, France, 72000

3

CHU Poitiers

Poitiers, France, 86000