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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004840
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005766

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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