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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003404
Receipt No. R000003341
Scientific Title Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Date of disclosure of the study information 2010/04/01
Last modified on 2014/05/30

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Basic information
Public title Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Acronym Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Scientific Title Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Scientific Title:Acronym Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the clinical efficacy and safety of new new collagen substitutes incorporating basic fibroblast growth factor for chronic skin ulcers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Improvement of wound 2 weeks after implantation
Key secondary outcomes 1.adverse event
2.wound area
3.granulation area

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Application of artificial dermis
(7microgram/ cm2 of trafermin)
Interventions/Control_2 Application of artificial dermis
(14microgram/ cm2 of trafermin)
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.Patient's ulcer has been present for a minimum of 1 month
2. Maximum area of ulcer is within 70mmx100mm
3.Skin Perfusion Pressure at the proximal margin or distal
margin of patient's ulcer(existing in lower extremity) is more than 30mmHg.
4.age: =>20
5. patients providing written informed consent
Key exclusion criteria 1.Decubitus with pocket
2.Patient's ulcer is with extensive exposure of tendon or bone
3.Ulcer with a infection
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigehiko Suzuki
Organization Kyoto University Hospital
Division name department of Plastic and Reconstructive surgery
Zip code
Address 54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL 075-751-4460
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Morimoto
Organization Kyoto University Hospital
Division name department of Plastic and Reconstructive surgery
Zip code
Address 54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL 075-751-4460
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 29 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003341

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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