UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003312
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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