Trial Condition(s):
Peripheral Arterial Disease
Iloprost therapy in patients with critical limb ischemia
Bayer Identifier:
15439
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
| Locations | |
|---|---|
Locations Investigative Site Many locations, Hungary | 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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