UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061680 |
|---|---|
| Receipt number | R000069739 |
| Scientific Title | A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/25 16:50:46 |
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Basic information
Public title
A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions
Acronym
A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions
Scientific Title
A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions
Scientific Title:Acronym
A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions
Region
| Japan |
Condition
Condition
Children (and adults) with severe physical and mental disabilities
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical outcomes of an intervention using a donut-shaped cushion for treating pressure ulcers of the auricular region in children and adults with severe physical and mental disabilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WeeFIM: Healing Progression and Evaluation of the DESIGN-R2020 Following the Use of Donut-Shaped Cushions for Auricular Pressure Ulcers in Patients with a WeeFIM Score of 18 (Very Severe and Near-Very Severe Cases).
Key secondary outcomes
WeeFIM: Incidence of auricular pressure ulcers in children and adults with a WeeFIM score of 18 (severe) or 17 (moderately severe)
Improvement rate of pressure ulcers with the use of donut-shaped cushions in cases of auricular pressure ulcers
Improvement rate of pressure ulcers in cases treated with methods other than donut-shaped cushions
Incidence of complications associated with the use of donut-shaped cushions
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | months-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population consisted of approximately 200 patients admitted to Hospital A who were classified as extremely severely disabled children or adults, or near-extremely severely disabled children or adults, due to conditions such as cerebral palsy or hypoxic encephalopathy. These patients had severe physical disabilities and severe intellectual disabilities, and required continuous respiratory management, nutritional management, and repositioning. All patients had a WeeFIM score of 18. We will conduct a retrospective study of these patients to analyze the occurrence of pressure ulcers and associated risk factors.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | SHIGEKI |
| Middle name | |
| Last name | BANBA |
Organization
Shiga University of Medical Science Hospital
Division name
School of Medicine, Department of Nursing, Division of Basic Nursing (Biochemistry, Pharmacology, and Nutrition)
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu City, Shiga Prefecture
TEL
077-548-2111
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | SHINSUKE |
| Middle name | |
| Last name | TERADA |
Organization
Shiga University of Medical Science Graduate School
Division name
Graduate School of Medicine, Department of Nursing
Zip code
524-0012
Address
Seta Tsukinowa-cho, Otsu City, Shiga Prefecture
TEL
077-548-2111
Homepage URL
terawoc@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu City, Shiga Prefecture
Tel
077-548-2111
terawoc@belle.shiga-med.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 25 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the 200 children and adults with a WeeFIM score of 18 the Mann Whitney U test will be used for continuous variables eg age weight albumin levels and the chi square test for nominal variables in the intergroup comparison of background factors Patients were classified into a present group and an absent group based on the occurrence of auricular pressure ulcers and logistic regression analysis was used to analyze the factors contributing to pressure ulcer development The efficacy of each treatment method donut shaped cushion pressure relieving bedding ointment application and wound dressings was evaluated in 23 patients who developed auricular pressure ulcers For the analysis the start date of each treatment method will be used as the baseline with the date of pressure ulcer healing defined as the event occurrence date and the observation period ending on the date of discharge or when the outcome is unknown The Kaplan Meier method will be used to estimate the number of days until healing of the auricular pressure ulcer and survival curves between treatment groups will be compared Furthermore the Cox proportional hazards model will be used to conduct a multivariate analysis of the effect of introducing each treatment method on the time to healing
Management information
Registered date
| 2026 | Year | 05 | Month | 25 | Day |
Last modified on
| 2026 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069739
