UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Title of the study (Brief title)	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	Hiroshi Mizuno
Organization	Nippon Medical School
Division name	Department of Plastic and Reconstructive Surgery
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603
TEL
Email

Public contact
Name of contact person
Organization	Nippon Medical School
Division name	Department of Plastic and Reconstructive Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001297