CompletedNot Applicable

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

France603 participantsStarted 2016-02-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline (pre-inclusion visit)

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

Timeframe: Day 1 (inclusion visit)

Trial details

NCT IDNCT02637492

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-04

View on ClinicalTrials.gov More Lower Limb Ischaemia trials