UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of wound management based on biofilm detection at bed side: a randomized controlled trial
Title of the study (Brief title)	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	Gojiro Nakagami
Organization	The University of Tokyo
Division name	Graduate School of Medicine
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	Gojiro Nakagami
Organization	The University of Tokyo
Division name	Graduate School of Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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