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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037089
Receipt No. R000041758
Scientific Title The prospective observational study on footcare methods for improve the nail hyperkeratosis caused by onychomycosis
Date of disclosure of the study information 2019/06/17
Last modified on 2020/09/06

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Basic information
Public title The prospective observational study on footcare methods for improve the nail hyperkeratosis caused by onychomycosis
Acronym The prospective observational study on footcare methods for improve the nail hyperkeratosis caused by onychomycosis
Scientific Title The prospective observational study on footcare methods for improve the nail hyperkeratosis caused by onychomycosis
Scientific Title:Acronym The prospective observational study on footcare methods for improve the nail hyperkeratosis caused by onychomycosis
Region
Japan

Condition
Condition Diabetes
Onychomycosis
Classification by specialty
Endocrinology and Metabolism Dermatology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the nail hyperkeratosis caused by onychomycosis in outpatients for Diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The infection area ratio
Key secondary outcomes Extension of the new nail
hypertrohied nail
spo2
Palus rate
ABI(Ankie Brachial index)
Hallux valgus
Pegeon toe

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 Diabetes
Tinea unguium
Total dystrophic onychomycosis or distal lateral subungual onychomycosis
Key exclusion criteria KOH negative people
Patients who do not agree to participate
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Misa
Middle name
Last name Ohnishi
Organization Asahi Rousa Hospital
Division name Nursing Department Asahi Rousai Hospital
Zip code 4888585
Address 61Hirakokita,Owariasahi,Aichi,Japan
TEL 0561-54-3131
Email misasora.kuma.akabanatonakai@gmail.com

Public contact
Name of contact person
1st name Misa
Middle name
Last name Ohnishi
Organization Asahi Rousai Hospital
Division name Nursing Department Asahi Rousai Hospital
Zip code 4888585
Address 61 Hirakokita,Owariasahi,Aichi,Japan
TEL 090-2680-6224
Homepage URL
Email misasora.kuma.akabanatonakai@gmail.com

Sponsor
Institute Asahi Rousai Hospital
Institute
Department

Funding Source
Organization Social insurance Union Societies Related Nursing
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor Aikawa Comprehensive Internal Medicine Clinic
Kumasaka Internal Medicine Clinic
Visit nursing station Yamashina Co.Ltd
Kato clinic
OGATA FAMILY CLINIC
Housing type pay nursing home yumeka
ALION I nc.
Japan Eco Care Service Co., Ltd.
Japan Eco Care Service Co.,Ltd.Nijinooka Tateyama
Japan Eco Care Service Co.,Ltd.Nijinooka Sangou
Japan Eco Care Service Co.,Ltd.Nijinooka Gokiso
Visit nursing station Uphindo
Emz consulting,Co.Ltd.Day service nukumorinoie obatakita
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahi Rousai Hospital
Address 61 Hirakokita,Owariasahi,Aichi,Japan
Tel 0561-54-3131
Email misasora.kuma.akabanatonakai@gmail.com

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 独立行政法人労働者健康安全機構旭ろうさい病院(愛知県)
相川みんなの診療所(愛知県)
熊坂内科医院(岩手県)
訪問看護ステーション山品(愛知県)
加藤医院(愛知県)
おがたファミリークリニック(愛知県)
住宅型有料老人ホーム夢幻(愛知県)
株式会社ALION(愛知県)
ケアプラン夢ライフイリコ(愛知県)
日本エコ・ケア・サービス(愛知県)
株式会社日本エコ・ケア・サービス 虹の丘 たてやま(富山県)
株式会社日本エコ・ケア・サービス 虹の丘 三郷(富山県)
株式会社日本エコ・ケア・サービス 虹の丘 御器所(愛知県)
アップヒンド訪問看護ステーション(愛知県)
株式会社エムズコンサルティング デイサービスぬくもりの家小幡北(愛知県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 17 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
2019 Year 06 Month 05 Day
Date of IRB
2019 Year 06 Month 05 Day
Anticipated trial start date
2019 Year 06 Month 05 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: The prospective observational study

Management information
Registered date
2019 Year 06 Month 17 Day
Last modified on
2020 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041758

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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