UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010268 |
|---|---|
| Receipt number | R000012015 |
| Scientific Title | Topical application of novel anti-microbial peptide, AG30/5C, for cutaneous ulcers |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2017/06/28 17:19:00 |
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Basic information
Public title
Topical application of novel anti-microbial peptide, AG30/5C, for cutaneous ulcers
Acronym
Topical application of AG30/5C for cutaneous ulcers
Scientific Title
Topical application of novel anti-microbial peptide, AG30/5C, for cutaneous ulcers
Scientific Title:Acronym
Topical application of AG30/5C for cutaneous ulcers
Region
| Japan |
Condition
Condition
Cutaneous ulcers
Classification by specialty
| Geriatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine 1) the safety issue and 2) efficacy (wound size or anti-bacterial action) of topically-applied novel peptide, AG30/5C, as a first in human trial for cutaneous ulcers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Wound size
Anti-bacterial action
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topical treatment of AG30/5C (100microg/mL)twice a day for 11 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients with diabetes, peripheral arterial diseases, and Buerger diseases.
2. uncured cutaneous ulcer for more than one month
3. detection of MRSA in ulcer
4. no infection of cutaneous ulcer
5. no infection of other cutaneous ulcer
6. no systematic infection
7. over 20 years old
8. agreement with patient
Key exclusion criteria
1. Patients with complication of alcohol and drug intoxication
2. History of malignant tumor
3. Tumor multiplication in ulcer
4. Infection with HIV, HBV, HCV, HTLV-1
5. Pregnancy
6. Osteomyelitis of ulcer
7. Unsuitable patients judged by investigators
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Rakugi |
Organization
Osaka University
Division name
Department of Geriatric Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3852
rakugi@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Nakagami |
Organization
Osaka University
Division name
Division of Vascular Medicine and Epigenetics
Zip code
Address
2-1 Yamadaoka, Suita, Osaka
TEL
06-6879-3406
Homepage URL
nakagami@gts.med.osaka-u.ac.jp
Sponsor or person
Institute
Medical Center for Translational Research, Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Biomedical Innovation
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 18 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012015
