UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022258 |
|---|---|
| Receipt number | R000025648 |
| Scientific Title | clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2017/05/12 16:50:14 |
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Basic information
Public title
clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers
Acronym
PRP for the treatment of cutaneous ulcers
Scientific Title
clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers
Scientific Title:Acronym
PRP for the treatment of cutaneous ulcers
Region
| Japan |
Condition
Condition
chronic cutaneous ulcer
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of autologous platelet rich plasma for the treatment of chronic cutaneous ulcers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
More than 50 per cent epithelialization after 4 or 8 week
Key secondary outcomes
Per cent of ulcer decrease in area
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
| Other |
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
Patient with an ulcer of at least one month's duration
Key exclusion criteria
Screening platelet count < 150 x 109/L
Uncontrolled infection at under
Patient has active cancer
Screening hemoglobin <8.0 mg/dL
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Shiga University of Medical Science
Division name
Dermatology
Zip code
Address
Seta-tsukinowa, Otsu city, Shiga Japan
TEL
81-77-548-2381
tnderma@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Shiga University of Medical Science
Division name
Dermatology
Zip code
Address
Seta-tsukinowa, Otsu city, Shiga Japan
TEL
81-77-548-2381
Homepage URL
tnderma@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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 | 05 | Month | 16 | 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
2 subjects,
effectiveness:1 effective, 1 not effective
safety:no problem
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
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 10 | Day |
Last modified on
| 2017 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025648
