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

Lower Limb Ischaemia Clinical Trial

— PREDICCMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637492
• Other study ID #: CHUBX 2013/26
• Status: Completed
• Start date: February 15, 2016
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: February 1, 2022
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Lower Limb Ischaemia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Limoges	Limoges
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Predicted event: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions		Day 1 (inclusion visit)
Secondary	Possible predictor: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions		Day 1 (inclusion visit)
Secondary	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)
Secondary	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)