UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029684 |
|---|---|
| Receipt number | 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 10:39:34 |
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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
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
gojiron-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033924
