UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015689 |
|---|---|
| Receipt number | R000017643 |
| Scientific Title | An exploratory clinical trial using platelet-rich plasma in patients with chronic skin ulcers |
| Date of disclosure of the study information | 2014/11/14 |
| Last modified on | 2015/11/24 13:38:31 |
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Basic information
Public title
An exploratory clinical trial using platelet-rich plasma in patients with chronic skin ulcers
Acronym
clinical trial using PRP in patients with chronic skin ulcers
Scientific Title
An exploratory clinical trial using platelet-rich plasma in patients with chronic skin ulcers
Scientific Title:Acronym
clinical trial using PRP in patients with chronic skin ulcers
Region
| Japan |
Condition
Condition
chronic skin ulcers
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 safety and effficacy of the platelet-rich plasma (PRP) in the treatment of chronic skin ulcers compared to those of the conventional therapy .
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Time until wound closure
The number of days from the administration of PRP to wound closure, spontaneous wound closure or wound closure by a simple surgical procedure is evaluated.
Key secondary outcomes
*Percentage of wound reduction
*The improvement of blood flow-The Skin perfusion pressure or Ankle brachial index
*The correlation of Time until wound closure to the platelet count or growth factor levels in PRP
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
| Device,equipment |
Interventions/Control_1
Activated Platelet-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
1.Patients aged 20 years or older at informed consent.
2.Written informed consent.
3.Presence of chronic skin ulcers not healing for at least 1 month with conventional treatments.
4.Expected to be closed by autologous skin grafting or suturing after PRP treatment
Key exclusion criteria
1.Patients showing unstable hemodynamics due to ischemic heart disease, or impair blood coagulation as in clotting disorders.
2.Patients taking anticoagulants or antithrombotics judged by the investigator or sub-investigator to be inappropriate as subjects since the drugs may affect the clotting system.
3.Have any of the following systemic diseases.
*Uncontrolled diabetes mellitus:HbA1c not lower than 10% according to latest laboratory data obtained within 28 days before registration
*Requiring continued use of oral corticosteroid therapy >20 mg/day prednisolone equivalent.
*A history of malignant tumor with disease-free interval of 3 years or less
4.Patients who are or may be pregnant
5.Other patients judged by the investigator or sub-investigator to be inappropriate as a subject of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kusumoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka,
TEL
0728040101
prs@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Morimoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
0728040101
Homepage URL
http://www.kmu.ac.jp/hirakata/
morimotn@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical 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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 14 | 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
| 2014 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017643
