Acceleration Time Assessment for Prediction of Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

— ATACLI  

Official title:

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296576
• Other study ID #: CHM-2023/S49/06
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 our 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 431
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

Intervention

Procedure:
• arterial ultrasound scan
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

Locations

Country	Name	City	State
France	Centre Hospitalier de CHOLET	Cholet
France	Centre Hospitalier du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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