UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023289 |
|---|---|
| Receipt number | R000026846 |
| Scientific Title | Establishment of Regenerative Therapy for Intractable Wound |
| Date of disclosure of the study information | 2016/07/25 |
| Last modified on | 2019/03/16 16:06:31 |
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Basic information
Public title
Establishment of Regenerative Therapy for Intractable Wound
Acronym
Regenerative Therapy for Wound Healing
Scientific Title
Establishment of Regenerative Therapy for Intractable Wound
Scientific Title:Acronym
Regenerative Therapy for Wound Healing
Region
| Japan |
Condition
Condition
Intractable peripheral artery disease (arteriosclerosis obliterans and thronboangiitis obliterans) and intractable skin ulcer
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Wound healing effect by controlled release platelet rich plasma (PRP) regenerative therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Efficacy determination by the changes of wound size and granulation recovery 4 weeks after treatment or termination period
Key secondary outcomes
Major adverse event and resting pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Platelet rich plasma(PRP) will be prepared from autologous peripheral blood sample.
Autologous PRP 1.8ml will be impregnated with biodegradable gelatin microsphere (180mg).
Prepared controlled release PRP will be injected into the muscle by 10 points.
Interventions/Control_2
Hyperbaric oxygen therapy will be performed(every day to 3times per week until 20 times will be terminated).
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
Intractable ulcer due to any cause, which complicated with disability of daily life. Intractable by means out of indication or no response to conventional medical treatment at least 3 months.
Key exclusion criteria
Any infections by osteomyelitis or multiple resistant bacteria, which unable to control by antibiotics alone. Any malignant disease, which was treated within 5 years. Who need treatment (surgical approach) in addition to present treatment.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Takagi |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113 8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo. Japan
TEL
03-3822-2131
gen52@nms.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Takagi |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113 8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo. Japan
TEL
03-3822-2131
Homepage URL
gen52@nms.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
JSPS-Kakenhi
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
IRB-Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
inq-ccr@nms.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NB3150006
Org. issuing International ID_1
The Japanese Association for the Promotion of State-of-the-Art in Medicine (JAPSAM)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 25 | 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
| 2015 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026846
