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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001068
Receipt No. R000001297
Scientific Title Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Date of disclosure of the study information 2009/03/31
Last modified on 2016/11/29

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Basic information
Public title Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Acronym Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Scientific Title Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Scientific Title:Acronym Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Region
Japan

Condition
Condition Skin ulcers
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe and evaluate the treatment of skin ulcers using gelatin sheet incorporating basic fibroblast growth factor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wound closure by spontaneous healing or skin graft
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Application of gelatin sheet incorporated basic fibroblast growth factor
Interventions/Control_2 Standard wound care
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Skin ulcers, burn ulcers and pressure sores without infection
Key exclusion criteria Patients were excluded if they had active infection, or malignant disease within 5 years. Written informed consent was obtained from all patients.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Mizuno
Organization Nippon Medical School
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nippon Medical School
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL 03-5814-6208
Homepage URL
Email hmizuno@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 日本医科大学(勤務地変更のため、現在一時中断中。新勤務地で再開予定)

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 31 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 Completed
Date of protocol fixation
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 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
2008 Year 03 Month 06 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001297

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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