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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025486
Receipt No. 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 2017/07/04

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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
Middle name
Last name Hisae Hayashi
Organization Seijoh University
Division name Faculty of Rehabilitation and Care
Zip code
Address 2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL 052-601-6000
Email hisaehayashi@seijoh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisae Hayashi
Organization Seijoh University
Division name Faculty of Rehabilitation and Care
Zip code
Address 2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL 052-601-6000
Homepage URL
Email hisaehayashi@seijoh-u.ac.jp

Sponsor
Institute Study group for prevention and rehabilitation of the lower extremity chronic wounds
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
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
2017 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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