UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059849 |
|---|---|
| Receipt number | R000068439 |
| Scientific Title | Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy; A randomized, non-blinded, comparative study |
| Date of disclosure of the study information | 2025/11/21 |
| Last modified on | 2025/11/21 14:58:59 |
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Basic information
Public title
Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy; A randomized, non-blinded, comparative study
Acronym
Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy
Scientific Title
Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy; A randomized, non-blinded, comparative study
Scientific Title:Acronym
Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy; A randomized, non-blinded, comparative study
Region
| Japan |
Condition
Condition
Diabetic peripheral neuropathy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of warm-water footbaths and carbonated-water footbaths on peripheral neuropathy and peripheral blood flow in patients with diabetic peripheral neuropathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the sural nerve conduction velocity and action potential amplitude before and after the intervention, as well as changes in peripheral blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Carbonated footbath group
Participants will receive a footbath using carbonated water generated by a carbonated water generator (Carbo Ceramini, Mitsubishi Chemical Aqua Solutions) for 10 minutes per day over 5 days.
Interventions/Control_2
Warm-water footbath group
Participants will receive a footbath with warm tap water for 10 minutes per day over 5 days.
Interventions/Control_3
Control group
No intervention will be provided.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older and under 80 years
2) Patients with type 2 diabetes who have been diagnosed with diabetic peripheral neuropathy
3) Patients currently hospitalized
Key exclusion criteria
1) Patients with diabetic foot gangrene
2) Patients after lower-limb amputation
3) Patients judged as unsuitable by the attending physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hisayuki |
| Middle name | |
| Last name | Katsuyama |
Organization
National Kohnodai Medical Center
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
2728516
Address
Kohnodai 1-7-1, Ichikawa-shi, Chiba, Japan
TEL
0473723501
katsuyama.h@jihs.go.jp
Public contact
Name of contact person
| 1st name | Hisayuki |
| Middle name | |
| Last name | Katsuyama |
Organization
National Kohnodai Medical Center
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
2728516
Address
Kohnodai 1-7-1, Ichikawa-shi, Chiba, Japan
TEL
0473723501
Homepage URL
katsuyama.h@jihs.go.jp
Sponsor or person
Institute
National Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, National Institute for Health Security
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo
Tel
0332027181
kenkyu-shinsa@hosp.ncgm.go.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 21 | 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
45
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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068439
