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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023969
Receipt No. R000027592
Scientific Title Therapy of refractive skin ulcer by using platelet rich plasma
Date of disclosure of the study information 2016/09/07
Last modified on 2018/03/14

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Basic information
Public title Therapy of refractive skin ulcer by using platelet rich plasma
Acronym Treatment of ulcer by PRP
Scientific Title Therapy of refractive skin ulcer by using platelet rich plasma
Scientific Title:Acronym Treatment of ulcer by PRP
Region
Japan

Condition
Condition decubitus and refractive skin ulcer(excepting cosmetic surgery)
Classification by specialty
Dermatology Orthopedics Cardiovascular surgery
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Regenerative medicine for refractive skin ulser
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes wound heeling with reepithelization after 8 weeks.
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
Maneuver
Interventions/Control_1 administration(once a week, Max 8 times)
dosage(1mL of ten folds concentrated plate-rich plasma)
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 To meet all of the following conditions.
1) no effect on FGF-2 or occulutive negative pressure treatment for 28 days.
2) case of reject following therapy
a. amptation
b. skin graft
c. other surgical approach
3) ill systemic condition for operation
4) patient who can collect the venous blood for PRP production
5) over 20 years old
6) patient who can take a informed consent
Key exclusion criteria If any of the following items.
1) patients who can not control the infection of the wound surface.
2) the wound surface (ulcer) with malignancy
3) significant anemia (both men and women less than Hb 7g / dL)
4) leukemia
5) aplastic anemia
6) thrombocytopenia
7) blood coregration abnormality
8) no compliance
9) no agreement
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Aihara
Organization St.Marianna University School of Medecine
Division name Dept. of Plastic and Reconstructive Surgery
Zip code
Address 2-16-1 Sugao, Miyamae, Kawasaki, JAPAN
TEL 044-977-8111
Email m2aihara@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Inoue
Organization St.Marianna University School of Medecine
Division name Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Zip code
Address 2-16-1 Sugao, Miyamae, Kawasaki, JAPAN
TEL 044-977-8111
Homepage URL
Email h2inoue@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medecine
Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Institute
Department

Funding Source
Organization St.Marianna University School of Medecine
Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 09 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2016 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
2016 Year 09 Month 07 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027592

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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