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| ID | Type | Description | Link |
|---|---|---|---|
| VE1011HU | Other Identifier | Company Internal |
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Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost (Ilomedin, BAYQ6256) | Drug | Prescription and treatment of Iloprost will be decided by physicians |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of limb pain at rest assessed by visual analogue scale | Pain relief will be defined as complete relief of pain while off analgesics | At baseline, at the end of iloprost treatment, at follow-up visits ( month 3, 6, 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ulcer healing | 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 amputations |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Hungary |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| 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) |
| 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) |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |