UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004840 |
|---|---|
| Receipt number | R000005766 |
| Scientific Title | Clinical study for the treatment of chronic wounds using Platelet-rich Plasma |
| Date of disclosure of the study information | 2011/01/07 |
| Last modified on | 2012/02/10 09:27:46 |
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Basic information
Public title
Clinical study for the treatment of chronic wounds using Platelet-rich Plasma
Acronym
PRP therapy for chronic wounds
Scientific Title
Clinical study for the treatment of chronic wounds using Platelet-rich Plasma
Scientific Title:Acronym
PRP therapy for chronic wounds
Region
| Japan |
Condition
Condition
Pressure ulcer, Foot ulcer
Classification by specialty
| Cardiology | Vascular surgery | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tretment of chronic wounds using PRP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the period for complete wound closure
Key secondary outcomes
In case complete wound closure is unsuccessful, we will apply the evaluation of wound condition, wound area, formation of granulation tissue, epithelialization of wound margin, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Local injection of PRP together with standard therapy using ointment and dressing materials
Interventions/Control_2
Standard therapy using ointment and dressing materials
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Chronic or unstable skin ulcer
2.Written informed consent by patient himself
Key exclusion criteria
1.anemia
2.thrombocytopenia
3.local infection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Maegawa |
Organization
Yokohama City University Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Maegawa |
Organization
Yokohama City University Hospital
Division name
Plastic and Reconstructive Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Local Government
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 07 | Day |
Last modified on
| 2012 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005766
