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. 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
Information provided by:
Medical University of Vienna

Brief Summary:
The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.

Condition or disease
Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia
Study Start Date : January 2011

one group only
all participants

Primary Outcome Measures :
  1. death [ Time Frame: 5 years ]
  2. ipsilateral amputation rate [ Time Frame: 5 years ]
  3. stroke [ Time Frame: 5 years ]
  4. myocardial infarction [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary care centre

Inclusion Criteria:

  • Chronic (> 2 weeks) critical limb ischemia in one or both of the lower extremities with necrosis and/or gangrene in the limb (peripheral artery disease IV according to Fontaine's classification or Rutherford stage 5 & 6) of whatever genesis (atherosclerotic, aneurysmatic, embolic, inflammatory)
  • ankle/brachial index < 0.4 or toe pressure < 30 mmHg
  • Ability to give written informed consent

Exclusion Criteria:

  • o Ulceration exclusively due to nonvascular causes like neuropathy (without coexisting hemodynamic impairment as defined above) or venous ulceration (without coexisting arterial impairment as defined above)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01233141

Contact: Silvia Charwat-Resl, MD +43140400 ext 4670
Contact: Martin Schillinger, MD +4340400 ext 4670

Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Silvia Charwat-Resl, MD    +43140400 ext 4670   
Principal Investigator: Silvia Charwat-Resl, MD         
Sponsors and Collaborators
Medical University of Vienna

Responsible Party: Silvia Charwat, Medical University of Vienna Identifier: NCT01233141     History of Changes
Other Study ID Numbers: VICLI-2010
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: November 2010

Keywords provided by Medical University of Vienna:
peripheral artery disease stage IV (Fontaine's classification) or stage 5 and 6 (Rutherford's classification

Additional relevant MeSH terms:
Pathologic Processes