Iloprost Therapy in Patients With Critical Limb Ischemia

Peripheral Arterial Disease Clinical Trial

Official title:

Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458041
• Other study ID #: 15439
• Secondary ID: VE1011HU
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: February 27, 2015
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Council of Scientific And Research Ethics
• Study type: Observational

Clinical Trial Summary

Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who fulfill the internationally defined criteria of critical limb ischemia;

• Patients who are not eligible for vascular surgery or angioplasty interventions and

• Patients who are treated with iloprost infusion.

• The treating physician has decided iloprost treatment before study enrollment.

Exclusion Criteria:

• Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Iloprost (Ilomedin, BAYQ6256)
Prescription and treatment of Iloprost will be decided by physicians

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of limb pain at rest assessed by visual analogue scale	Pain relief will be defined as complete relief of pain while off analgesics	At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)	No
Secondary	Incidence of ulcer healing		at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)	No
Secondary	Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputations		at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)	No
Secondary	Mortality and/or severe cardiovascular events (AMI, stroke)		at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)	Yes
Secondary	Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scanner		at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)	No
Secondary	Changes of transcutaneously measured tissue oxygen tension values		at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)	No

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