UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019885 |
|---|---|
| Receipt number | R000022808 |
| Scientific Title | Effect of Plasma Derived Exosomes on Cutaneous Wound Healing |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2016/11/20 09:21:13 |
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Basic information
Public title
Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
Acronym
Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
Scientific Title
Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
Scientific Title:Acronym
Effect of Plasma Derived Exosomes on Cutaneous Wound Healing
Region
| Japan |
Condition
Condition
The participants are patients with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns).
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the effect of autologous exosomes rich plasma on cutaneous wound healing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Ulcer size (length, width, depth, mm)
[Time Frame: 28 days]
Key secondary outcomes
Pain of cutaneous wounds (Visual Analog Score for pain)
[Time Frame: 28 days]
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
28 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with intractable cutaneous ulcers (e.g. rheumatic disease, peripheral arterial disease, chronic venous insufficiency, decubitus or burns)
Key exclusion criteria
Patients who have ulcers with bone involvement.
Patients who have ulcers with a history or suspected neoplasia.
Patients who are in chemotherapy or radiation therapy on the skin ulcers.
Patients with marked immunodeficiency (i.e., patients with severe liver failure, heart failure, hematologic failure or endocrine failure)
Patients who have clinical signs of malnutrition or serum albumin <2 mg / dL.
Patients who have severe infection.
Patients who are pregnant or breastfeeding.
Patients who are participating in another study.
Patients who are judged inappropriate for this trial by their attending physician.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Jinnin |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
Address
1-1-1 Honjo Kumamoto, Japan
TEL
096-373-5233
mjin@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Jinnin |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
Address
1-1-1 Honjo Kumamoto, Japan
TEL
096-373-5233
Homepage URL
mjin@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
2012
Org. issuing International ID_1
Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
熊本大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | 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
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2016 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
