UMIN-CTR Clinical Trial

Basic information
Public title	Beneficial effects of foot care nursing for people with diabetes mellitus: An uncontrolled before and after intervention.
Acronym	effects of foot care nursing for people with diabetes mellitus
Scientific Title	Beneficial effects of foot care nursing for people with diabetes mellitus: An uncontrolled before and after intervention.
Scientific Title:Acronym	effects of foot care nursing for people with diabetes mellitus
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We develope a nurse-based diabetic foot care program based on the International Working Group on the Diabetic Foot. The aim of present study is to investigate the effectiveness of foot care nursing in preventing diabetic foot ulceration.
Basic objectives2	Others
Basic objectives -Others	We are divided into patients 0 to 3 risk groups according to the IWGDF risk classification.During the 2-year program, each patient received 30-60 min foot care, once a year to once every 1-6 months depending on the risk category. We evaluate the incidence of foot ulceration or recurrence and non-ulcerated foot condition.
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We evaluate the incidence of diabetic foot ulceration or recurrence and non-ulcerated foot (callus and tinea pedes) condition.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We are divided into patients 0 to 3 risk groups according to the IWGDF risk classification.During the 2-year program, each patient received 30-60 min foot care, once a year to once every 1-6 months depending on the risk category. We evaluate the incidence of foot ulceration or recurrence and non-ulcerated foot condition.
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	patients are refered to diabetes care unit from outpatient clinic of the endocrinology at Osaka University Hospital.Among that patients who attend our foot care program for 2 consecutive years.
Key exclusion criteria	We excluded those patients with orthopedic diseases, cranial nerve disorders, impaired cognitive function, mental disorders, and those on chemotherapy. We also excluded those who did not adhere to our 2-year program.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Iichiro Shimomura
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Metabolic Medicine
Zip code
Address	2-2-B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yuko Fujiwara
Organization	Osaka University Hospital
Division name	Diabetes Care Unit
Zip code
Address	2-15, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL	06-6879-5391
Homepage URL
Email	f_yuko@hosp.med.osaka-u.ac.jp

Sponsor
Institute	Diabetes Care Unit and Department of Metabolic Medicine, Osaka University Hospital
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
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

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 24 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	2009 Year 05 Month 25 Day
Date of IRB	2009 Year 05 Month 25 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2011 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	2010 Year 03 Month 17 Day
Last modified on	2020 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004065