peripheral arterial disease
Conditions
Interventions
Intravenous infusion of adrenomedullin (1.5 pmol/kg/min) for 8 hour per day (09:00 to 17:00) up to 2 weeks (14 days)
Sponsors
First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fulfill following all conditions; 1. Patients who have any obstruction or stenosis of superficial femoral artery and/or popliteal artery and/or further peripheral arteries in one of angiography, CT-angiography and MRI, and have resulting clinical symptoms included rest pain, nonhealing ischemic ulcers and intermittent claudication within 200 m walking 2. Patients who did not respond to conventional therapy included non-surgical and surgical revascularization
Exclusion criteria
Exclusion criteria: Any condition following; 1. malignancy 2. severe liver dysfunction 3. acute myocardial infarction, unstable angina, myocarditis and stroke within one month 4. active infection 5. pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvements 1. Fontaine IV: improvement of ischemic ulcers (at least 25% reduction in size) 2. Fontaine III: improvement of rest pain (at least 2 cm reduction in VAS) 3. Fontaine IIb: improvement of walking distance (at least 20% increase in ICD and/or ACD), and/or ABPI (at least 20% increase) | — |
Secondary
| Measure | Time frame |
|---|---|
| skin perfusion pressure dose of analgesics QOL ABPI/TPI thermography vascular echo angiography laser Doppler tcpO2 | — |
Countries
Japan
Contacts
Public ContactToshihiro Kita
Faculty of Medicine, University of Miyazaki First Department of Internal Medicine
Outcome results
None listed