Acceleration Time Assessment for Prediction of Critical Limb Ischemia

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.

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de CHOLET, Cholet, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arterial ultrasound scan

Procedure

An arterial ultrasound scan of the lower limbs with pulsed Doppler analysis of arterial flow spectra over the abdominal aorta, dorsal artery of the foot and lateral plantar artery, bilaterally

Primary outcomes

Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot

Time frame: 12 months

The diagnosis of Critical Limb ischaemia will be defined by a toe systolic pressure ≤ 30 mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU

CONTACT

[email protected]

+33244710781

Jean-Eudes TRIHAN, MD

CONTACT

[email protected]

02 41 49 62 49

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: ATACLI

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 6, 2024
Registry last updated: Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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