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Iloprost Therapy in Patients With Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01458041
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Peripheral Arterial Disease Drug: Iloprost (Ilomedin, BAYQ6256)

Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iloprost Therapy in Patients With Critical Limb Ischemia: Evaluation of Efficacy and Safety
Study Start Date : August 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

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




Primary Outcome Measures :
  1. 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 :
  1. Incidence of ulcer healing [ Time Frame: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458041


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01458041     History of Changes
Other Study ID Numbers: 15439
VE1011HU ( Other Identifier: Company Internal )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: February 2015

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
Vasodilator Agents