Iloprost Therapy in Patients With Critical Limb Ischemia
- Registration Number
- NCT01458041
- Lead Sponsor
- Bayer
- Brief Summary
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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.
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Exclusion Criteria
- Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Iloprost (Ilomedin, BAYQ6256) -
- Primary Outcome Measures
Name Time Method Change of limb pain at rest assessed by visual analogue scale 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
Name Time Method 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) Incidence of ulcer healing 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)