Skip to main content
OpenTrials
Completed

NCT Number: NCT02637492

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Limb Ischaemia 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 Arterial Occlusive Disease 1 Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Collection of clinical signs and symptoms

Other

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

Primary outcomes

  1. Possible predictors: Clinical signs and symptoms collected on a specific clinical chart developed by investigators

    Time frame: Baseline (pre-inclusion visit)

    The specific clinical chart will be completed by 2 investigators independently in order to assess the reproductibility as well.

  2. Predicted event: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions

    Time frame: Day 1 (inclusion visit)

Secondary outcomes

  1. Possible predictor: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions

    Time frame: Day 1 (inclusion visit)

  2. Predicted event: number of dead participants

    Time frame: Every year during study (up to 3 years)

    The vital status will be collected for every participant every year

  3. Predicted event: number of participants who underwent amputation

    Time frame: Every year during study (up to 3 years)

    The amputation occurrence will be collected for every participant every year

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PREDICCMI

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Dec 22, 2015
Registry last updated
Mar 14, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.