UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030587 |
|---|---|
| Receipt number | R000034818 |
| Scientific Title | Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2017/12/27 11:19:17 |
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Basic information
Public title
Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Acronym
Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Scientific Title
Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Scientific Title:Acronym
Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to investigate footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence for patients with daiabtes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the presence or absence of diabetic complications, foot lesions, subjective symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
To assess severity of foot ulcer based on the risk classification chart incorporating the DPNCheck-based neuropathy assessment in patients with diabetes, implement periodic follow-up footcare intervention at a frequency based on the risk, and verify efficacy of the foot care intervention program
The time for each intervention is 30-60min
care.
The contents of intervention; the checking of foot conditons and footcare behaiviors,nail clipping,and callus treatment,supports of selfcare.
risk0(normal);every a year
risk1(mild) ;every 6 months
risk2(moderate);every 3-4months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who had a clear understanding, participated voluntarily, and consented to the study in writing after receiving sufficient explanation pertaining to participation in the study
Key exclusion criteria
1.Those who were judged by the physician or nurse to be physically and mentally unsuitable for participating in the study
2.Those who were judged by the physician or nurse to have difficulty in self-expression and undertaking foot care (cleaning, foot observation, trauma prevention, and topical application) on their own, because of psychiatric disorders or dementia
3.Those who expressed inability to perform long-term activities, such as cleaning their own foot because of upper limb or finger disorders, or were judged by the physician or nurse to have such inabilities (excluding those who could not perform the tasks temporarily because of injury)
4.Those who expressed difficulty in reading the informed consent document required for participating in this study, because of vision disorders
5.Others who were judged by the physician or the nurse to be unsuitable as participants
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masuko Sumikawa |
Organization
Sapporo Medical University
Division name
Department of Nursing School of Health Science
Zip code
Address
Minami 1 Nishi 17 Chuo-Ku,Sapporo
TEL
011-611-2111
masuko0811@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masuko Sumikawa |
Organization
Sapporo Medical University
Division name
Department of Nursing School of Health Science
Zip code
Address
Minami 1 Nishi 17 Chuo-Ku,Sapporo
TEL
011-611-2111
Homepage URL
masuko0811@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 12 | 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
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034818
