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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010268
Receipt No. 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

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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
Email 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
Email nakagami@gts.med.osaka-u.ac.jp

Sponsor
Institute Medical Center for Translational Research, Osaka University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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