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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003312
Receipt No. 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

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Basic information
Public title Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Acronym Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Scientific Title Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Scientific Title:Acronym Therapeutic neovascularization using intravenous adrenomedullin infusion for limb ischemia
Region
Japan

Condition
Condition peripheral arterial disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 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)
Key secondary outcomes skin perfusion pressure
dose of analgesics
QOL
ABPI/TPI
thermography
vascular echo
angiography
laser Doppler
tcpO2

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kitamura
Organization Faculty of Medicine, University of Miyazaki
Division name First Department of Internal Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-0872
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kita
Organization Faculty of Medicine, University of Miyazaki
Division name First Department of Internal Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-0872
Homepage URL
Email t-kita@po.sphere.ne.jp

Sponsor
Institute First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2009 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 10 Day
Last modified on
2010 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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