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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name