Acceleration Time Assessment for Prediction of Critical Limb Ischemia (ATACLI)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: arterial ultrasound scan

• Study Type: Observational
• Enrollment (Estimated): 431

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +33244710781; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: Jean-Eudes TRIHAN, MD; Phone Number: 02 41 49 62 49; Email: j.eudes.trihan@gmail.com

Study Locations

• France
  • Cholet, France, 49300
    • Recruiting
    • Centre Hospitalier de Cholet
    • Contact: Marie GAUME; Email: marie.gaume@ch-cholet.fr
    • Principal Investigator: Jean-Eudes TRIHAN, MD
  • Le Mans, France, 72000
    • Not yet recruiting
    • Centre Hospitalier du Mans
    • Contact: Christelle JADEAU; Phone Number: 02 44 71 07 81; Email: cjadeau@ch-lemans.fr
    • Principal Investigator: Claire NEVEUX-BRECHETEAU, MD
  • Poitiers, France, 86000
    • Recruiting
    • CHU Poitiers
    • Contact: Magali CROQUETTE, MD; Phone Number: 0549443570; Email: magali.croquette@chu-poitiers.fr
    • Principal Investigator: Magali CROQUETTE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient referred to the vascular medicine department of one of the investigating centres for arterial Doppler ultrasound of at least one lower limb

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot	The diagnosis of Critical Limb ischaemia will be defined by a toe systolic pressure ≤ 30 mmHg	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: critical limb ischaemia; systolic rise time
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: CHM-2023/S49/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No