UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Topical application of novel anti-microbial peptide, AG30/5C, for cutaneous ulcers
Title of the study (Brief title)	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	Hiromi Rakugi
Organization	Osaka University
Division name	Department of Geriatric Medicine
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3852
Email	rakugi@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person	Hironori Nakagami
Organization	Osaka University
Division name	Division of Vascular Medicine and Epigenetics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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