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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015102
Receipt No. R000017569
Scientific Title Research of wound bed preparation for Negative Pressure Wound Therapy
Date of disclosure of the study information 2014/09/10
Last modified on 2018/03/14

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Basic information
Public title Research of wound bed preparation for Negative Pressure Wound Therapy
Acronym NPWT study
Scientific Title Research of wound bed preparation for Negative Pressure Wound Therapy
Scientific Title:Acronym NPWT study
Region
Japan

Condition
Condition Diabetic foot ulcer
Classification by specialty
Endocrinology and Metabolism Infectious disease Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to reveal which factor is the most significant on Negative pressure wound therapy to treat Diabetic foot ulcers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1:Infection control
2:Glycemic control
3:Blood flow
4:Nutrition
5:Negative pressure setting
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Negative Wound Therapy for lower extremity wound
Key exclusion criteria 1:other infectious disease
2:Collagen disease,Malignant disease
3:non revascularized CLI
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsumoto Kengo
Organization Oitaoka Hospital
Division name Plastic Surgery Department Wound Care Center
Zip code
Address Nishitsurusaki oita city Japan 3-7-11
TEL 097-522-3131
Email nekimiss@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Fukada Masashi
Organization Oitaoka Hospital
Division name Drug discovery center
Zip code
Address Nishitsurusaki oita city Japan 3-7-11
TEL 097-522-3131-2202
Homepage URL
Email okajimukyoku@oka-hp.com

Sponsor
Institute Oitaoka Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Oitaoka Hospital
Organization
Division
Category of Funding Organization Self funding
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 社会医療法人敬和会大分岡病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 No longer recruiting
Date of protocol fixation
2014 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 31 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information Prospective study

Case Control Sampling

Management information
Registered date
2014 Year 09 Month 10 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017569


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