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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036558
Receipt No. R000041583
Scientific Title Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Date of disclosure of the study information 2019/04/21
Last modified on 2019/04/20

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Basic information
Public title Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Acronym Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on diabetic foot patients
Scientific Title Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Scientific Title:Acronym Effects of belt electrode skeletal muscle electrical stimulation (B-SES) on diabetic foot patients
Region
Japan

Condition
Condition Diabetic Foot
Peripheral Arterial Disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of belt electrode skeletal muscle electrical stimulation (B-SES) on leg function and ambulatory state during the bed rest period after surgery for diabetic foot patients.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Range of Motion (Ankle Joint)
Key secondary outcomes Lower limb strength
Ambulatory State
Size of wounds
Plantar load of walking
Physical activities (IPAQ)
QOL(EQ-5D-5L)
Skin Perfusion Pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 In addition to rehabilitation mainly consisted of ROMex and Strength Training, B-SES is applied on bilateral lower limbs.
Interventions/Control_2 Rehabilitation mainly consisted of ROMex and Strength Training.
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 1)admitted to the hospital for treatment of diabetic foot ulcers or ischemic ulcers

2)ambulated until one week before hospitalization

3)wound infections were controlled
Key exclusion criteria 1)underwent major amputation.

2)worsened lower limb symptom or general condition of patients due to postoperative complications.

3)other coexisting diseases which made rehabilitation more difficult (or long term hospitalization)

4) patients who do not agree to this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shinsuke
Middle name
Last name Imaoka
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Community-based Rehabilitation Sciences
Zip code 852-8102
Address 1-7-1 Sakamoto Nagasaki
TEL 095-819-7994
Email ptssinnsukeimaoka@yahoo.co.jp

Public contact
Name of contact person
1st name Shinsuke
Middle name
Last name Imaoka
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Community-based Rehabilitation Sciences
Zip code 852-8102
Address 1-7-1 Sakamoto Nagasaki
TEL 095-819-7994
Homepage URL
Email ptssinnsukeimaoka@yahoo.co.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization None
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 Nagasaki University Graduate School of Biomedical Sciences
Address 1-7-1 Sakamoto Nagasaki
Tel 095-819-7994
Email ptssinnsukeimaoka@yahoo.co.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
2019 Year 04 Month 21 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
2019 Year 03 Month 16 Day
Date of IRB
2019 Year 03 Month 20 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 20 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041583

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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