UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009860
Receipt number R000011555
Scientific Title Treatment of cutaneous ulcer using platelet-rich plasma
Date of disclosure of the study information 2013/01/24
Last modified on 2015/07/24 19:54:40

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Basic information

Public title

Treatment of cutaneous ulcer using platelet-rich plasma

Acronym

PRP therapy for cutaneous ulcer

Scientific Title

Treatment of cutaneous ulcer using platelet-rich plasma

Scientific Title:Acronym

PRP therapy for cutaneous ulcer

Region

Japan


Condition

Condition

cutaneous ulcer

Classification by specialty

Cardiology Vascular surgery Dermatology
Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of PRP therapy for cutaneous ulcer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

condition of cutaneous ulcer

Key secondary outcomes



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 Maneuver

Interventions/Control_1

application of PRP to ulcer

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

1.refractory cutaneous ulcer
2.written informed consent

Key exclusion criteria

1.local infection
2.malignancies on the treatment site
3.thrombocytopenia(<50,000/micro-l)
4.difficulty in blood collection around 50ml
5.others judged inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Tamaki

Organization

National Center for Global Health and Medicine Center Hospital

Division name

Department of Dermatology

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, JAPAN

TEL

81-3-3202-7181

Email

ttamaki@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Tamaki

Organization

National Center for Global Health and Medicine Center Hospital

Division name

Department of Dermatology

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, JAPAN

TEL

0332027181

Homepage URL


Email

ttamaki@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

国立国際医療研究センター病院


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 09 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 12 Day

Last follow-up date

2013 Year 07 Month 31 Day

Date of closure to data entry

2013 Year 07 Month 31 Day

Date trial data considered complete

2013 Year 07 Month 31 Day

Date analysis concluded

2014 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 24 Day

Last modified on

2015 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name