Iloprost Therapy in Patients With Critical Limb Ischemia

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Drug: Iloprost (Ilomedin, BAYQ6256)

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Hungary
  • Many locations, Hungary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Iloprost (Ilomedin, BAYQ6256); Prescription and treatment of Iloprost will be decided by physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of ulcer healing	at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Quality of life; Iloprost; Visual analogue scale; Critical limb ischaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 15439; VE1011HU (Other Identifier: Company Internal)