UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000201
Receipt number R000000275
Scientific Title Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication
Date of disclosure of the study information 2005/09/13
Last modified on 2008/12/08 19:13:39

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Basic information

Public title

Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication

Acronym

Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication

Scientific Title

Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication

Scientific Title:Acronym

Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication

Region

Japan


Condition

Condition

Arteriosclerosis obliterance

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy of therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for the treatment of intermittent claudication

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Physical findings
Symptoms
Maximum walking distance and time
Ankle pressure index
Near-infrared spectroscopy
Transcutaneous oximetry
Skin perfusion pressure
Air plethysmography
Angiography

Key secondary outcomes

Adverse events

Serum FGF2 concentration


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

Intra-arterial injection of acidic gelatin hydrogel microspheres (3mg) incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg)

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

40 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

1. Arteriosclerosis obliterance
2. Fontaine II
3. Main occlusive disease is located in femoral artery or more distal part.
4. Written informed consent

Key exclusion criteria

1. Hypersensitivity for gelatin hydrogel
2. Serious medical co-morbidities
3. Alcoholism or other drug dependence within 3 months
4. Malignancy within 5 years
5. Possibility of malignancy
6. Operations within 3 months
7. Severe diabetic retinopathy
8. Pregnant woman, lactating woman
9. Vascular reconstruction within 2 months
10. Other complication unsuitable for the study

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuro Miyata

Organization

The University of Tokyo Hospital

Division name

Department of Surgery, Division of Vascular Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-8411

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Koyama

Organization

The University of Tokyo Hospital

Division name

Department of Vascular Regeneration

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-8411

Homepage URL

http://plaza.umin.ac.jp/kekkan/

Email

hkoyama-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Science, Sports and Culture

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

The University of Tokyo, Division of Tissue Engineering

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



Other administrative information

Date of disclosure of the study information

2005 Year 09 Month 13 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

Date of protocol fixation

2004 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2008 Year 09 Month 01 Day

Date of closure to data entry

2009 Year 03 Month 01 Day

Date trial data considered complete

2009 Year 03 Month 01 Day

Date analysis concluded

2009 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 13 Day

Last modified on

2008 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000275


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name