Viennese Registry on Patients With Chronic Critical Limb Ischemia

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01233141
• Other study ID #: VICLI-2010
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2010
• Last updated: July 27, 2011
• Start date: January 2011

Study information

• Verified date: November 2010
• Source: Medical University of Vienna
• Contact: Silvia Charwat-Resl, MD
• Phone: +43140400
• Email: silvia.charwat[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		5 years	No
Primary	ipsilateral amputation rate		5 years	No
Primary	stroke		5 years	No
Primary	myocardial infarction		5 years	No