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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009860
Receipt No. 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

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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
Institute National Center for Global Health and Medicine
Institute
Department

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
URL(English) https://upload.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


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