UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003347 |
|---|---|
| Receipt number | R000004065 |
| Scientific Title | Beneficial effects of foot care nursing for people with diabetes mellitus: An uncontrolled before and after intervention. |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2020/09/24 13:06:28 |
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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
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
f_yuko@hosp.med.osaka-u.ac.jp
Sponsor or person
Institute
Diabetes Care Unit and Department of Metabolic Medicine, Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004065
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
