Trial Condition(s):
Peripheral Arterial Disease
Iloprost therapy in patients with critical limb ischemia
Study Completed
Trial Purpose
Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
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.
Trial Summary
Enrollment Goal
126
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Ilomedin (Iloprost, BAYQ6256)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
Status
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Many locations, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Change of limb pain at rest assessed by visual analogue scalePain relief will be defined as complete relief of pain while off analgesicsTimeframe: At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12)
Secondary Outcome
- Incidence of ulcer healingTimeframe: 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 amputationsTimeframe: 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)Timeframe: 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 scannerTimeframe: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
- Changes of transcutaneously measured tissue oxygen tension valuesTimeframe: at baseline, at the end of iloprost treatment and at follow-up visits ( month 3, 6, 12)
Additional Information
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