check_circleStudy Completed

Peripheral Arterial Disease

Bayer Identifier:

15439

ClinicalTrials.gov Identifier:

NCT01458041

EudraCT Number:

Not Available

EU CT Number:

Not Available
Iloprost therapy in patients with critical limb ischemia

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 are in accordance with the Summary of Product Characteristics of Ilomedin.

Trial summary

Enrollment Goal
126
Trial Dates
August 2011 - December 2014
Phase
N/A
Could I Receive a placebo
No
Products
Ilomedin (Iloprost, BAYQ6256)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Hungary

Primary Outcome

  • Change of limb pain at rest assessed by visual analogue scale
    Pain relief will be defined as complete relief of pain while off analgesics
    date_rangeTime Frame:
    At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Incidence of ulcer healing
    date_rangeTime Frame:
    at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    No
  • Collection of interventional / surgical procedures including 1) Rate of revascularization procedures; 2) Minor amputations; 3) Frequency and height of major amputations
    date_rangeTime Frame:
    at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    No
  • Mortality and/or severe cardiovascular events (AMI, stroke)
    date_rangeTime Frame:
    at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    Yes
  • Hemodynamic measurements: peripheral arterial blood flow and pressure on ankle / hallux level by Doppler scanner
    date_rangeTime Frame:
    at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    No
  • Changes of transcutaneously measured tissue oxygen tension values
    date_rangeTime Frame:
    at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Iloprost therapy in patients with critical limb ischemia: evaluation of efficacy and safety
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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