Unique ID issued by UMIN | UMIN000003312 |
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Receipt number | R000004009 |
Scientific Title | Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia |
Date of disclosure of the study information | 2010/03/10 |
Last modified on | 2010/03/10 17:05:58 |
Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Japan |
peripheral arterial disease
Cardiology |
Others
NO
Universal and safety methods are desirable for clinical application of adrenomedullin. Continuous intravenous infusion of adrenomedullin fulfills the conditions, and is expected to be useful for therapy of limb ischemia. No-option patients with critical limb ischemia are increasing along with progressive increase of atherosclerotic diseases in aging society, so effective and safety neovasculization method is in demand. Adrenomedullin strongly inhibits apoptosis of vascular endothelial cells and epithelial progenitor cells, and has own effects of neovasculization and vascular dilatation. The purpose of this study is to confirm the safety and efficacy of adrenomedullin infusion for limb ischemia in clinical setting.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
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)
skin perfusion pressure
dose of analgesics
QOL
ABPI/TPI
thermography
vascular echo
angiography
laser Doppler
tcpO2
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
10
1st name | |
Middle name | |
Last name | Kazuo Kitamura |
Faculty of Medicine, University of Miyazaki
First Department of Internal Medicine
5200 Kihara, Kiyotake, Miyazaki, Japan
0985-85-0872
1st name | |
Middle name | |
Last name | Toshihiro Kita |
Faculty of Medicine, University of Miyazaki
First Department of Internal Medicine
5200 Kihara, Kiyotake, Miyazaki, Japan
0985-85-0872
t-kita@po.sphere.ne.jp
First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Ministry of Health, Labour and Welfare
Japan
NO
宮崎大学医学部附属病院
2010 | Year | 03 | Month | 10 | Day |
Unpublished
Preinitiation
2009 | Year | 11 | Month | 16 | Day |
2010 | Year | 04 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2010 | Year | 03 | Month | 10 | Day |
2010 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004009
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