Lower Limb IschaemiaPREDICCMINCT02637492
Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)
An observational study of Lower Limb Ischaemia, run by University Hospital, Bordeaux at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Ischaemia
- What is being tested?
- Collection of clinical signs and symptoms
- How many people
- 603 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Feb 2016to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for peripheral occlusive arterial disease
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux
Bordeaux, 33075
CHU de Limoges
Limoges, 87042
CHU de Toulouse
Toulouse, 31059
About this study
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.
Read the 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.
- Conditions
- Lower Limb Ischaemia
- Being tested
- Collection of clinical signs and symptoms
- Keywords
- Critical limb ischaemia, Peripheral occlusive arterial disease, Clinical prediction, Ankle pressure, Transcutaneous oxygen pressure, Toe pressure, Microcirculation
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of clinical signs and symptomsOther
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
| Study group | Role | What they receive |
|---|---|---|
| ICCMI | Patient hospitalized for lower limb arterial disease and suspected to have critical ischaemia Receives: Other: Collection of clinical signs and symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-inclusion visit)
Predicted event: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions
Measured: Day 1 (inclusion visit)
Secondary outcomes (3)
Possible predictor: number of participants with diagnosis of Critical Lower Limb Ischaemia according to TASC I and II definitions
Measured: Day 1 (inclusion visit)
Predicted event: number of dead participants
The vital status will be collected for every participant every year
Measured: 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
Measured: Every year during study (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start15 Feb 2016
- Primary completion4 Feb 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb IschaemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, Study chair, USMR, CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637492
- Sponsor's protocol ID
- CHUBX 2013/26
- Acronym
- PREDICCMI
- Status last verified
- Mar 2022
- First submitted
- 20 Nov 2015
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Clinical Prediction Rule for Lower Limb Critical Limb Ischaemia (PREDICCMI)
- ClinicalTrials.gov ID
- NCT02637492
- Acronym / sponsor ID
- PREDICCMI / CHUBX 2013/26
- Conditions
- Lower Limb Ischaemia
- Keywords
- Critical limb ischaemia, Peripheral occlusive arterial disease, Clinical prediction, Ankle pressure, Transcutaneous oxygen pressure, Toe pressure, Microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICCMI | – | Other: Collection of clinical signs and symptomsPatient hospitalized for lower limb arterial disease and suspected to have critical ischaemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for peripheral occlusive arterial disease
Key inclusion criteria (3 listed)
- Patient coming for consultation or hospitalized for lower limb arterial disease and suspected to have critical ischaemia (ie rest pain or ulcer)
- Patient coming for consultation or hospitalized for lower limb arterial disease without rest pain
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of clinical signs and symptomsCollection 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 | Other | ICCMI |
Primary outcome
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.
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)
3 secondary outcomes
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)
Predicted event: number of dead participants
Time frame: Every year during study (up to 3 years)
Predicted event: number of participants who underwent amputation
Time frame: Every year during study (up to 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul PEREZ study chair
USMR, CHU de Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Ischaemia, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Possible predictors: Clinical signs and symptoms collected on a specific clinical chart developed by investigators (time frame: Baseline (pre-inclusion visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.