UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021044 |
|---|---|
| Receipt number | R000023592 |
| Scientific Title | The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers |
| Date of disclosure of the study information | 2016/02/17 |
| Last modified on | 2017/08/19 18:16:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Acronym
The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Scientific Title
The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Scientific Title:Acronym
The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Region
| Japan |
Condition
Condition
refractory cutaneous uclers
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the efficacy and safety of the treatment using the platelet-rich plasma(PRP) to intractable skin ulcers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to wound closure (days)
We evaluate the length of time (days) from the administration of PRP to full-epithelialization or to when the wound become closed by a simple surgical closure.
Key secondary outcomes
We evaluate side reaction such as wound healing delayed, excessive inflammation about treatment with platelet-rich plasma.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
<platelet-rich plasma>
We administer PRP(1-several cc)to the wound in a single dose according to size of the wounded area and evaluate effect of treatment at 1,2,4,6 and 8 weeks after initiation of the therapy. Additional administration of PRP is considered after having obtained patient's consent after start of therapy depending on a state of the wounded area every two weeks. As for the observation and the duration of treatment, we do it with eight weeks, but extend this period to limit in 16 weeks when it shows an effect, and subjects hope for continuation of this treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 18 over or older at informed consent.Written informed consent.
2)Patient with intractable cutaneous ulcer without the improvement or with the exacerbation by a conventional therapy.
3)Patients who have difficulty in treatment with surgery due to physical states.
4)Patients during ambulatory care,
Key exclusion criteria
1) Patients with severe anemia (7 g/dl of Hb or less)
2)Patients with thrombocytopenia(less than Plt 150,000/ul)
3)Other patients judged by the investigator to be inappropriate as subjects of this study.
4)The hospitalized patients.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takehara |
Organization
Kanazawa University
Division name
Department of Dermatology
Zip code
Address
13-1 Takaramachi,Kanazawa,Ishikawa
TEL
07622652342
hifuka-jimu@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akito Komuro |
Organization
Kanazawa University
Division name
Division of Plastic and Reconstructive Surgery,Department of Dermatology
Zip code
Address
13-1 Takaramachi,Kanazawa,Ishikawa
TEL
07622652342
Homepage URL
komuro@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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 | 02 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 23 | 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 | 02 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023592
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
