Viennese Registry on Patients With Chronic Critical Limb Ischemia

Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Silvia Charwat-Resl, MD; Phone Number: 4670 +43140400; Email: silvia.charwat@meduniwien.ac.at
    • Principal Investigator: Silvia Charwat-Resl, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

tertiary care centre

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
one group only; all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
myocardial infarction	5 years
stroke	5 years
death	5 years
ipsilateral amputation rate	5 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 27, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: peripheral artery disease stage IV (Fontaine's classification) or stage 5 and 6 (Rutherford's classification
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: VICLI-2010