UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023969 |
|---|---|
| Receipt number | 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 | 2019/09/10 15:45:10 |
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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
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
h2inoue@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medecine
Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027592
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
