UMIN-CTR Clinical Trial

Basic information
Public title	Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire)
Acronym	Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire)
Scientific Title	Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire)
Scientific Title:Acronym	Satisfaction survey of diabetic patients treated for pain or numbness in the feet and legs (online questionnaire)
Region	Japan

Condition
Condition	Diabetic peripheral neuropathic pain
Classification by specialty	Medicine in general Endocrinology and Metabolism Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the level of satisfaction of diabetic patients treated for pain or numbness in the feet and legs.
Basic objectives2	Others
Basic objectives -Others	Observational research
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Level of satisfaction of patients treated for painful feet and legs
Key secondary outcomes	1.Reason for the level of satisfaction with treatment of painful feet and legs 2.Level of communication with their physician 3.Level of improvement in daily activities after treatment of painful feet and legs 4.Level of improvement in quality of life (QOL) after treatment of painful feet and legs 5.Awareness of the cause of pain symptoms 6.Preference in pain treatment

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.Patients receiving outpatient treatment of diabetes at the time of study enrollment 2.Patients having painful or numb feet and legs and consulting their physician about the symptom at the time of study enrollment 3.Age >=20years at the time of obtaining consent 4.Patients who are able to understand the study procedures, answer questions properly, and consent to study participation
Key exclusion criteria	Market research, advertising /marketing, media, healthcare workers, people involved in pharmaceutical companies
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Nakagaki
Organization	DAIICHI SANKYO CO., LTD.
Division name	Medical Science Department
Zip code	103-8426
Address	3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL	03-6225-1053
Email	nakagaki.hisashi.sh@daiichisankyo.co.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Takatsuna
Organization	DAIICHI SANKYO CO., LTD.
Division name	Medical Science Department
Zip code	103-8426
Address	3-5-1 Nihonbashi Honcho Chuo-ku, Tokyo, 103-8426, Japan
TEL	03-6225-1053
Homepage URL
Email	takatsuna.hiroshi.wb@daiichisankyo.co.jp

Sponsor
Institute	DAIICHI SANKYO CO., LTD.
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitamachi clinic
Address	1-1-3 Kitamachi, Musashino-city, Tokyo
Tel	070-5011-8550
Email	shingo-namiki@cmicgroup.com

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	2020 Year 10 Month 02 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	Completed
Date of protocol fixation	2020 Year 08 Month 27 Day
Date of IRB	2020 Year 08 Month 19 Day
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2020 Year 10 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Web Questionnaire Study of Diabetic Peripheral Neuropathic Pain

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2021 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047897

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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