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Iloprost Therapy in Patients With Critical Limb Ischemia

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: October 10, 2011
Last updated: February 27, 2015
Last verified: February 2015
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.

Condition Intervention
Peripheral Arterial Disease
Drug: Iloprost (Ilomedin, BAYQ6256)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of limb pain at rest assessed by visual analogue scale [ Time Frame: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12) ]
    Pain relief will be defined as complete relief of pain while off analgesics

Secondary Outcome Measures:
  • Incidence of ulcer healing [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) ]

Enrollment: 126
Study Start Date: August 2011
Study Completion Date: December 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Iloprost (Ilomedin, BAYQ6256)
Prescription and treatment of Iloprost will be decided by physicians


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01458041

Many locations, Hungary
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT01458041     History of Changes
Other Study ID Numbers: 15439
VE1011HU ( Other Identifier: Company Internal )
Study First Received: October 10, 2011
Last Updated: February 27, 2015

Keywords provided by Bayer:
Critical limb ischaemia
Quality of life
Visual analogue scale

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on May 25, 2017