UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008428 |
|---|---|
| Receipt number | R000009913 |
| Scientific Title | Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds |
| Date of disclosure of the study information | 2012/07/26 |
| Last modified on | 2022/05/23 11:25:01 |
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Basic information
Public title
Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds
Acronym
PRP treatment of ulcers with HA scaffolds
Scientific Title
Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds
Scientific Title:Acronym
PRP treatment of ulcers with HA scaffolds
Region
| Japan |
Condition
Condition
Refractory ulcers, Foot ulcers
Classification by specialty
| Cardiology | Vascular surgery | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of PRP tretment of refractory ulcers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
reduction ratio of wound area
Key secondary outcomes
period for complete wound closure, mean times of PRP application, mean platelet concentration, pathological examination of granulation tissue, epithelialization of wound margin, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Local injection of PRP with hyaluronic acid scaffolds together with standard therapy using ointment and dressing materials
Interventions/Control_2
Standard therapy using ointment and dressing materials
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Chronic or unstable skin ulcer
2.Written informed consent by patient himself
Key exclusion criteria
1.anemia
2.thrombocytopenia
3.local infection
4.malignancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanobu MASHIKO |
Organization
Saitama Medical Center
Division name
Plasctic and Cosmetic Surgery
Zip code
Address
1981Kamoda, Kawagoe, Saitama
TEL
049-228-3400
takanobu-mashiko@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanobu MASHIKO |
Organization
Saitama Medical Center
Division name
Plasctic and Cosmetic Surgery
Zip code
Address
1981Kamoda, Kawagoe, Saitama
TEL
049-228-3400
Homepage URL
takanobu-mashiko@umin.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center
Organization
Division
Category of Funding Organization
Local Government
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
| 2012 | Year | 07 | Month | 26 | 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
| 2012 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009913
