UMIN-CTR Clinical Trial

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	Main results already published
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	2021 Year 04 Month 21 Day
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	2022 Year 04 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041583