UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025486 |
|---|---|
| Receipt number | R000029328 |
| Scientific Title | The influence of initial rehabilitation timing on ambulatory status and medical expenses for patients with lower-extremity chronic wounds: Multicenter block-randomized controlled trial |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2022/07/28 14:36:13 |
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Basic information
Public title
The influence of initial rehabilitation timing on ambulatory status and medical expenses for patients with lower-extremity chronic wounds: Multicenter block-randomized controlled trial
Acronym
The effects of rehabilitation for patients with lower-extremity chronic wounds: Multicenter randomized controlled trial
Scientific Title
The influence of initial rehabilitation timing on ambulatory status and medical expenses for patients with lower-extremity chronic wounds: Multicenter block-randomized controlled trial
Scientific Title:Acronym
The effects of rehabilitation for patients with lower-extremity chronic wounds: Multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
lower-extremity chronic wounds caused by diabetes and/or peripheral arterial disease
Classification by specialty
| Endocrinology and Metabolism | Vascular surgery | Orthopedics |
| Cardiovascular surgery | Plastic surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of initial rehabilitation timing on ambulatory status and medical expenses for patients with lower-extremity chronic wounds by multicenter randomized controlled trials.
Basic objectives2
Others
Basic objectives -Others
cost-effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Maintenance rate of ambulatory status
(at the time of discharge)
Key secondary outcomes
Medical expenses
Size of wounds
6 minute walking distance
Plantar load of walking
Physical activities (IPAQ)
QOL(EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention
start rehabilitation after surgical treatment
Interventions/Control_2
Control
stranded treatment and routine examination until complete wound healing and start rehabilitation after that
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
admitted to the hospital for treatment of diabetic foot ulcers or ischemic ulcers.
ambulated until one week before hospitalization.
wound infections were controlled.
Key exclusion criteria
underwent major amputation.
worsened lower limb symptom or general condition of patients due to postoperative complications.
other coexisting diseases which made rehabilitation more difficult (or long term hospitalization).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Hisae |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
4768588
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
hisaehayashi@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
4768588
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
Homepage URL
hisaehayashi@seijoh-u.ac.jp
Sponsor or person
Institute
Study group for prevention and rehabilitation of the lower extremity chronic wounds
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Research Ethics Committee of Seijoh University
Address
Fukinodai, Tokai City, Aichi Prefecture, Japan
Tel
052-601-6000
fujita@seijoh-u.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
大分岡病院（大分県）
名古屋共立病院（愛知県）
春日部中央総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 31 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029328
