UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of the footbath with soap bubble and warm compress with the footbath with warm water
Acronym	A comparison of the footbath with soap bubble and warm compress with the footbath with warm water
Scientific Title	A comparison of the footbath with soap bubble and warm compress with the footbath with warm water
Scientific Title:Acronym	A comparison of the footbath with soap bubble and warm compress with the footbath with warm water
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effectiveness of footbath with soap bubble and warm compress with the footbath with warm water
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin surface temperature
Key secondary outcomes	subjective evaluation

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	footbath with soap bubble and warm compress
Interventions/Control_2	footbath with warm water
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those with no foot diseases Those who do not have pain, ulcer, or inflammation on foots Those who have no skin diseases Those who have no experience of skin rash due to soap or cosmetics
Key exclusion criteria	Those with foot disease Those who have pain, ulcer, or inflammation on foots Those who have skin diseases Those who have experiences of skin rash due to soap or cosmetics
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Miho Middle name Last name Sato
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kitaku, Sapporo
TEL	011-706-3324
Email	m_sato@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Miho Middle name Last name Sato
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita12, Nishi5, Kitaku, Sapporo
TEL	011-706-3324
Homepage URL
Email	m_sato@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 16 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	6
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	2021 Year 06 Month 14 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 08 Month 16 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 14 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050839