UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005264 |
|---|---|
| Receipt number | R000005910 |
| Scientific Title | Application of hyaluronic acid and collagen sponge with epidermal growth factor (EGF) for intractable skin ulcers and burn ulcers |
| Date of disclosure of the study information | 2011/03/20 |
| Last modified on | 2022/12/09 17:19:58 |
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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
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
akanenaka@hotmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
