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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name