UMIN-CTR Clinical Trial

Basic information
Public title	Application of hyaluronic acid and collagen sponge with epidermal growth factor (EGF) for intractable skin ulcers and burn ulcers
Acronym	Application of EGF wound dressing for intractable skin ulcers and burn ulcers
Scientific Title	Application of hyaluronic acid and collagen sponge with epidermal growth factor (EGF) for intractable skin ulcers and burn ulcers
Scientific Title:Acronym	Application of EGF wound dressing for intractable skin ulcers and burn ulcers
Region	Japan

Condition
Condition	Intractable skin ulcers, burn ulcers, donor sites of skin grafts and traumatic skin defects
Classification by specialty	Dermatology Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of EGF wound dressing on wound healing in intractable skin ulcers and burn ulcers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	1. Wound area size 2. Granulation tissue formation 3. Extent of epithelialization 4. Infection 5. Macroscopic appearance
Key secondary outcomes	1. Effectiveness 2. Safety 3. Overall clinical evaluation

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 Device,equipment
Interventions/Control_1	EGF wound dressing is used for 6 weeks
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who has intractable skin ulcers (diabetic skin ulcers and burn ulcers), donor sites of skin grafts or traumatic skin defects. 2. Patients who agreed with their written informed consent
Key exclusion criteria	1. Patients with hypersensitivity to any of the study drugs 2. Patiests who have a history of malignancy at the wound site. 3. Patients who are considered to be unsuitable for this study by the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Takeda
Organization	Kitasato University School of Medicine
Division name	Department of Plastic and Aesthetic Surgery
Zip code	2520374
Address	15-2-2F, Sakaecho, Kanagawa-ku, Yokohama, Kanagawa
TEL	0454446022
Email	akanenaka@hotmail.com

Public contact
Name of contact person	1st name Akane Middle name Last name Yu
Organization	Kitasato University School of Medicine
Division name	Department of Plastic and Aesthetic Surgery
Zip code	2520374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL	042-778-9074
Homepage URL
Email	akanenaka@hotmail.com

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sagamihara Kyodo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Organization for Safety Assessment of Clinical Research
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
Tel	042-778-8111
Email	shienc@kitasato-u.ac.jp

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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 20 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	Open public recruiting
Date of protocol fixation	2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 03 Month 17 Day
Last modified on	2022 Year 12 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005910