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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029684
Receipt No. R000033924
Scientific Title Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Date of disclosure of the study information 2017/10/24
Last modified on 2017/10/24

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Basic information
Public title Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Acronym Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Scientific Title Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Scientific Title:Acronym Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Region
Japan Asia(except Japan)

Condition
Condition diabetic foot ulcers, pressure ulcers
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether wound management based on biofilm detection accelerates wound healing
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes wound healing status (Evaluated by DESIGN and DFU scale)
Key secondary outcomes Wound size reduction (Relative to baseline value)
Score reduction (Relative to baseline value)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 wound management based on biofilm detection
Interventions/Control_2 standard wound care without biofilm detection
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 Out clinic patients with diabetic foot ulcers or pressure ulcers
Key exclusion criteria Patients with platelet of 50,000/uL or lower
Patients with severe general condition
Patients with wounds in which treatments cannot be changed regardless of biofilm detection
Target sample size 148

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gojiro Nakagami
Organization The University of Tokyo
Division name Graduate School of Medicine
Zip code
Address Faculty of Medicine Bldg. 5-307, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3424
Email gojiron-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gojiro Nakagami
Organization The University of Tokyo
Division name Graduate School of Medicine
Zip code
Address Faculty of Medicine Bldg. 5-307, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3424
Homepage URL
Email gojiron-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 24 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
2017 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2017 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033924

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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