UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037089 |
|---|---|
| Receipt number | R000041758 |
| Scientific Title | Examination of footcare procedure to improve the nail hyperkeratosis caused by onychomycosis |
| Date of disclosure of the study information | 2019/06/17 |
| Last modified on | 2023/03/19 13:33:57 |
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Basic information
Public title
Examination of footcare procedure to improve the nail hyperkeratosis caused by onychomycosis
Acronym
Examination of footcare procedure to improve the nail hyperkeratosis caused by onychomycosis
Scientific Title
Examination of footcare procedure to improve the nail hyperkeratosis caused by onychomycosis
Scientific Title:Acronym
Examination of footcare procedure to 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
The purpose of this study is to evaluate the efficacy of onychomycosis footcare therapy (OFT), provided by the hospital, clinic, home-visit nursing, and nursing home, for treating hypertrophied nails in diabetic patients with onychomycosis.
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
vibration perception threshold
Touch Test
systolic
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Behavior,custom |
| Maneuver |
Interventions/Control_1
During the first year, examinations of onychomycosis treatment and blood flow improvement were conducted once every 3 months.
Interventions/Control_2
At the completion of the 1-year period, the presence of ringworm fungus was examined using KOH direct microscopy.
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
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
misasora.kuma.akabanatonakai@gmail.com
Sponsor or person
Institute
Asahi Rousai Hospital
Institute
Department
Personal name
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
AICHIPACK Co. Ltd.health care MORIYAMA
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahi Rousai Hospital
Address
61 Hirakokita,Owariasahi,Aichi,Japan
Tel
0561-54-3131
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歌(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）
株式会社アイチパック ヘルスケアもりやま
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
118
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
Completed
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
Change the study plan of the study that you have already registered, and add a description of the accompanying study that you plan to do now to the study registration.
Management information
Registered date
| 2019 | Year | 06 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041758
