Iloprost Therapy in Patients With Critical Limb Ischemia

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01458041
First received: October 10, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 126
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized patients

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458041

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01458041     History of Changes
Other Study ID Numbers: 15439, VE1011HU
Study First Received: October 10, 2011
Last Updated: April 11, 2014
Health Authority: Hungary: Council of Scientific And Research Ethics

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

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014