Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI) (PREDICCMI)

Critical limb ischaemia (CLI) is the most serious stage of peripheral occlusive arterial disease (POAD). Despite progress in the revascularization procedures, half these patients experience amputation or death after one year. One issue is to identify these subjects because aggressive treatment is necessary in those cases, while in others (ie leg ulcer in a patient with POAD but no rest lower limb ischaemia), revascularization will not be necessary. Then it would be useful to develop a simple score to help the physician to improve diagnosis of CLI.

Study Overview

• Status: Completed
• Conditions: Lower Limb Ischaemia
• Intervention / Treatment: Other: Collection of clinical signs and symptoms

Detailed Description

Today many patients with suspected critical limb ischaemia do not have objective assessment of limb ischaemia despite recommendations, mainly because of lack of vascular medicine units able to measure ischaemia with adequate methods such as toe pressure or TCpo2. It would be very useful to better identify the patients who need to be explored, or at least to have an evidence-based clinical assessment in those who cannot be explored . The objective is to develop a simple clinical prediction rule of critical lower limb ischaemia.

Two definitions are currently used for critical limb ischaemia. In both definitions, objective confirmation is needed for critical limb ischaemia by measurement of ankle pressure, toe pressure or transcutaneous oxygen pressure. These two latter measurements are mandatory in the numerous patients whose ankle pressure measurement is not possible (diabetes, chronic renal failure). Unfortunately few vascular medicine units exist to carry out these measurements, so that it would be useful to better identify those patients who need to be explored. In those who cannot be explored, better clinical assessment would also be very useful.

The investigators aim to develop a simple clinical prediction rule by completing a specific clinical chart in the patients hospitalized for peripheral occlusive arterial disease in Bordeaux, Toulouse and Limoges university hospital vascular medicine units and included in the COPART II cohort. Internal validation will be performed using cross-validation and bootstrap methods.

To achieve the secondary objective, the patients will be followed-up for the duration of the study (ie from 1 to 3 years) to evaluate the prediction of clinical outcomes (death or amputation) by both definitions of critical limb ischaemia.

• Study Type: Observational
• Enrollment (Actual): 603

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • CHU de Bordeaux
  • Limoges, France, 87042
    • CHU de Limoges
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for peripheral occlusive arterial disease

Description

Inclusion Criteria:

• Patient coming for consultation or hospitalized for lower limb arterial disease and suspected to have critical ischaemia (ie rest pain or ulcer)

Non inclusion Criteria:

• Patient coming for consultation or hospitalized for lower limb arterial disease without rest pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICCMI; Patient hospitalized for lower limb arterial disease and suspected to have critical ischaemia	Other: Collection of clinical signs and symptoms; Collection of clinical signs and symptoms used for developing a Clinical prediction rule of critical lower limb ischaemia (diagnosed by haemodynamic methods: ankle pressure, toe pressure-laser Doppler or photo-plethysmography, transcutaneous oxygen pressure) in patients with peripheral occlusive arterial disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible predictors: Clinical signs and symptoms collected on a specific clinical chart developed by investigators	The specific clinical chart will be completed by 2 investigators independently in order to assess the reproductibility as well.	Baseline (pre-inclusion visit)
Predicted event: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions		Day 1 (inclusion visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible predictor: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions		Day 1 (inclusion visit)
Predicted event: number of dead participants	The vital status will be collected for every participant every year	Every year during study (up to 3 years)
Predicted event: number of participants who underwent amputation	The amputation occurrence will be collected for every participant every year	Every year during study (up to 3 years)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Paul PEREZ, USMR, CHU de Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2016
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Transcutaneous oxygen pressure; Microcirculation; Critical limb ischaemia; Clinical prediction; Peripheral occlusive arterial disease; Ankle pressure; Toe pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: CHUBX 2013/26