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
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
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
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
