Acceleration Time Assessment for Prediction of Critical Limb Ischemia

NCT06296576 | Recruiting

• 1 other identifier: CHM-2023/S49/06
• Study Type: observational
• Target: 431
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Limb Ischemia

Keywords

systolic rise time; critical limb ischaemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (3)

Centre Hospitalier de CHOLET

Cholet, 49300, France

RECRUITING

Centre Hospitalier du Mans

Le Mans, 72000, France

NOT YET RECRUITING

CHU Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

Jean-Eudes TRIHAN, MD

CONTACT

02 41 49 62 49; j.eudes.trihan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-02

Locations

FR (3)