Viennese Registry on Patients With Chronic Critical Limb Ischemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01233141|
Recruitment Status : Unknown
Verified November 2010 by Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : November 3, 2010
Last Update Posted : July 28, 2011
|Condition or disease|
|Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs|
This is a prospective observational cohort study including consecutive patients with CLI. The study will be initiated as a single center evaluation and is intended to be step-wise expanded to a Vienna-wide systematic survey. The study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by Fontaine stage IV or Rutherford stages 5 & 6. The study will include all patients presenting with CLI to the participating centers including inpatients and outpatients.
Patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. The study will be continued at least until the 5 year data of the last included patient are available.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia|
|Study Start Date :||January 2011|
one group only
- death [ Time Frame: 5 years ]
- ipsilateral amputation rate [ Time Frame: 5 years ]
- stroke [ Time Frame: 5 years ]
- myocardial infarction [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233141
|Contact: Silvia Charwat-Resl, MD||+43140400 ext email@example.com|
|Contact: Martin Schillinger, MD||+4340400 ext firstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Silvia Charwat-Resl, MD +43140400 ext 4670 email@example.com|
|Principal Investigator: Silvia Charwat-Resl, MD|