UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015102
Receipt number 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 2021/03/16 10:01:46

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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



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



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 Matsumoto
Middle name -
Last name Kengo

Organization

Oitaoka Hospital

Division name

Plastic Surgery Department Wound Care Center

Zip code

8700192

Address

Nishitsurusaki oita city Japan 3-7-11

TEL

09061034201

Email

nekimiss@gmail.com


Public contact

Name of contact person

1st name Fukada
Middle name
Last name Masashi

Organization

Oitaoka Hospital

Division name

Drug discovery center

Zip code

870-0192

Address

Nishitsurusaki oita city Japan 3-7-11

TEL

097-522-3131-2202

Homepage URL


Email

okajimukyoku@oka-hp.com


Sponsor or person

Institute

Oitaoka Hospital

Institute

Department

Personal name



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

oitaokahospital

Address

oitacitynishitsurusaki

Tel

0975223131

Email

nekimiss@yahoo.co.jp


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

2021 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017569


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name