UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Acronym	New therapeutic angiogenesis for peripheral artery disease
Scientific Title	Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Scientific Title:Acronym	New therapeutic angiogenesis for peripheral artery disease
Region	Japan

Condition
Condition	Arteriosclerosis obliterans Buerger's disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of Growth Factor (FGF) containing solution for the patients with PAD (ASO, Buerger's disease), who are unresponsive to standard therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Evaluation for Incidence, Severity, and Seriousness of adverse event
Key secondary outcomes	Improvement of Fontaine and Rutherford Classification

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intramuscular injection of Growth Factor (FGF) containing solution
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with ASO or Buerger's disease (2) Patient whose Fontaine classification is 3-4 and Rutherford classification is 4-6 in either limb. (3) Patients with clinical improvement can not be obtained even after any existing medical and surgical treatment. (4) Patient who can receive the protocol treatment for either limb. (5) Patients who can give informed consent themselves in writing.
Key exclusion criteria	(1) Patients with life expectancy likely to be within one year due to complications. (2) Patients are scheduled for major lower limb amputation (3) Patients with angina, congestive heart failure, or ventricular arrhythmia requiring treatment. (4) Patients with myocardial infarction within three months. (5) Left ventricular ejection fraction below 25% (6) Patients with lower extremity revascularization within 3 months. (7) Patient who performed percutaneous coronary intervention, bypass surgery within 1 month. (8) Hemoglobin 7 g /dL or less (9) Platelet count 70,000 / uL or less (10) AST 100 IU or more, or ALT 100 IU or more (11) Patients with malignant neoplasm requiring treatment. (12) Patients with suspected infection and fever. (13) Patients with uncontrolled diabetes over HbA1c 10%. (14) Patients with diabetic proliferating retinopathy requiring treatment. (15) Alprostadil Alfadex (for injection), Alprostadil (injection solution), Argatroban (injection solution), Trafermin (recombinant) in patients who are difficult to stop the worsening of symptoms could be stopped before surgery preparation. (16) Patients with a history of severe drug allergy. (17) Patients with negative skin reaction to decision not test solution. (18) The females who are in pregnancy or lactation, may be pregnant, or are planning. (19) Patients with a history of alcohol or drug dependence in past year. (20) Patients who are considered unsuitable by other principal investigators.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Matsubara
Organization	Department of Cardiovascular Medicine
Division name	Kyoto Prefectural University of Medicine
Zip code	602-8566
Address	465 Kajii-chyo,Kamigyo-ku, Kyoto
TEL	075-251-5511
Email	matsubah@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Satoaki Middle name Last name Matoba
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	602-8566
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
TEL	+8100752515511
Homepage URL
Email	matoba@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kamigyo-ku, Kyoto
Tel	0752515511
Email	matoba@koto.kpu-m.ac.jp

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

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 18 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	No longer recruiting
Date of protocol fixation	2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2013 Year 05 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 03 Month 18 Day
Last modified on	2021 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006272