UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060096 |
|---|---|
| Receipt number | R000068697 |
| Scientific Title | The Effect of a Hybrid Therapy Combining Acoustic Stimulation and Therapeutic Footwear in Patients With Type 2 Diabetes: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/16 |
| Last modified on | 2025/12/16 14:03:55 |
* 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
Effects of Exercise Using Sound Stimulation and Therapeutic Footwear for the Prevention of Foot Wounds in Patients with Diabetes
Acronym
SAFE-FOOT Study
Scientific Title
The Effect of a Hybrid Therapy Combining Acoustic Stimulation and Therapeutic Footwear in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Scientific Title:Acronym
SHOE-SOUND Trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the effectiveness of a hybrid therapy that combines exercise therapy using auditory stimulation with shoe therapy for the prevention of foot ulcers in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum plantar pressure during self-paced comfortable walking at 12 months after initiation of the intervention.
Key secondary outcomes
Walking speed, step length, quadriceps strength, grip strength, and gait sway at 12 months after initiation of the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
In the control group, physical therapists provide standard exercise instruction, including guidance on exercise intensity and frequency, walking instruction, resistance exercise instruction, education on complication prevention, and self-monitoring guidance. The intervention period lasts for one year. We conduct evaluations at baseline and every three months following the exercise instruction. We use a 10-meter walk test at each participant's self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on the results. In addition, we monitor the incidence of foot abnormalities, such as calluses and fissures, as well as the occurrence of foot ulcers throughout the study period.
Interventions/Control_2
In the shoe-therapy group, we provide the same exercise instruction as in the control group and additionally provide diabetic-specific shoes. We instruct participants to wear these shoes consistently during exercise and daily outings, and to perform walking exercises at their self-selected comfortable walking speed. The intervention period lasts for one year. We conduct evaluations at baseline and every three months following the exercise instruction. We use a 10-meter walk test at each participant's self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on the results. In addition, we monitor the incidence of foot abnormalities, such as calluses and fissures, as well as the occurrence of foot ulcers throughout the study period.
Interventions/Control_3
In the hybrid-therapy group, we provide the same interventions as in the shoe-therapy group and additionally implement metronome-guided walking exercises at each participant's self-selected comfortable walking pace. The intervention period lasts for one year. We conduct evaluations at baseline and every three months following the exercise instruction. We use a 10-meter walk test at each participant's self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on these results. In addition, we monitor the incidence of foot abnormalities, such as calluses and fissures, as well as the occurrence of foot ulcers throughout the study period.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The eligibility criterion for participants is an age of 75 years or younger.
Key exclusion criteria
Exclusion criteria include participants who require orthopedic treatment; those with a history of central nervous system disorders; those with severe diabetic retinopathy or nephropathy; those with severe heart disease; those experiencing foot pain; and those deemed unsuitable for exercise therapy by a physician.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Suzuki |
Organization
Gifu University of Health Sciences
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
500-8281
Address
2-92 Higashiuzura, Gifu-shi, Gifu
TEL
058-274-5001
keisukedondon@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Suzuki |
Organization
Gifu University of Health Sciences
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
500-8281
Address
2-92 Higashiuzura, Gifu-shi, Gifu
TEL
058-274-5001
Homepage URL
k-suzuki@gifuhoken.ac.jp
Sponsor or person
Institute
Gifu University of Health Sciences
Institute
Department
Personal name
Keisuke Suzuki
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University of Health Sciences
Address
2-92 Higashiuzura, Gifu-shi, Gifu
Tel
058-274-5001
t-iwata@toyota.ac.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
岐阜県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068697
