UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061013 |
|---|---|
| Receipt number | R000069819 |
| Scientific Title | Effect of post-discharge support for continuing self-exercise on prevention of wound deterioration in patients with diabetic foot: a single-center randomized single-blind controlled trial |
| Date of disclosure of the study information | 2026/03/22 |
| Last modified on | 2026/03/22 21:00:37 |
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Basic information
Public title
Effect of post-discharge support for continuing self-exercise on prevention of wound deterioration in patients with diabetic foot
Acronym
DF-Exercise Trial
Scientific Title
Effect of post-discharge support for continuing self-exercise on prevention of wound deterioration in patients with diabetic foot: a single-center randomized single-blind controlled trial
Scientific Title:Acronym
DF-Exercise Trial
Region
| Japan |
Condition
Condition
Diabetic foot
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of post-discharge support for continuing self-exercise on the prevention of wound deterioration in patients with diabetic foot.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate of foot ulcer within 6 months after discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Post-discharge support program for continuing self-exercise. At discharge, patients are provided with educational video content on foot care and exercise therapy including foot inspection, footwear management, lower limb strengthening, and stretching. Patients watch the videos using their smartphones and record daily foot condition and self-care practices on a wound management sheet. Healthcare staff review the records during outpatient visits and provide feedback when necessary.
Interventions/Control_2
Standard discharge education. Patients receive usual verbal and written instructions regarding foot care and daily management at discharge.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for treatment of diabetic foot who receive rehabilitation therapy
Key exclusion criteria
Patients who have undergone lower limb or foot amputation
Patients with severe cognitive or mental impairment who cannot understand the study
Patients whose wound condition or general condition is unstable and cannot continue rehabilitation
Patients requiring assistance in activities of daily living due to visual impairment
Patients judged to be inappropriate by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | SHOHEI |
| Middle name | |
| Last name | MINATA |
Organization
Department of Rehabilitation, Oitaoka Hospital, Keiwakai Medical Corporation
Division name
Department of Rehabilitation
Zip code
870-0105
Address
3-7-11 Nishi-Tsurusaki, Oita City, Oita, Japan
TEL
097-522-3131
minatasyohei@gmail.com
Public contact
Name of contact person
| 1st name | SHOHEI |
| Middle name | |
| Last name | MINATA |
Organization
Department of Rehabilitation, Oitaoka Hospital, Keiwakai Medical Corporation
Division name
Department of Rehabilitation
Zip code
870-0105
Address
3-7-11 Nishi-Tsurusaki, Oita City, Oita, Japan
TEL
097-522-3131
Homepage URL
minatasyohei@gmail.com
Sponsor or person
Institute
Oitaoka Hospital, Keiwakai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Oitaoka Hospital, Keiwakai Medical Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Keiwakai Medical Corporation
Address
3-7-11 Nishi-Tsurusaki, Oita City, Oita, Japan
Tel
097-522-3131
minatasyohei@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069819
