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Viennese Registry on Patients With Chronic Critical Limb Ischemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01233141
First received: November 2, 2010
Last updated: July 27, 2011
Last verified: November 2010
History of Changes
  Purpose

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

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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • ipsilateral amputation rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma, urine


Estimated Enrollment: 400
Study Start Date: January 2011
Groups/Cohorts
one group only
all participants

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

tertiary care centre

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233141

Contacts
Contact: Silvia Charwat-Resl, MD +43140400 ext 4670 silvia.charwat@meduniwien.ac.at
Contact: Martin Schillinger, MD +4340400 ext 4670 martin.schillinger@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Silvia Charwat-Resl, MD     +43140400 ext 4670     silvia.charwat@meduniwien.ac.at    
Principal Investigator: Silvia Charwat-Resl, MD            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Silvia Charwat, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01233141     History of Changes
Other Study ID Numbers: VICLI-2010
Study First Received: November 2, 2010
Last Updated: July 27, 2011
Health Authority: Austria: Ethikkommission

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:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013