UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008761 |
|---|---|
| Receipt number | R000010291 |
| Scientific Title | Impact of Diabetes Mellitus on Critical Limb Ischemia with Below the Knee Disease |
| Date of disclosure of the study information | 2012/08/23 |
| Last modified on | 2012/08/23 22:43:26 |
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Basic information
Public title
Impact of Diabetes Mellitus on Critical Limb Ischemia with Below the Knee Disease
Acronym
Impact of Diabetes Mellitus on Critical Limb Ischemia with Below the Knee Disease
Scientific Title
Impact of Diabetes Mellitus on Critical Limb Ischemia with Below the Knee Disease
Scientific Title:Acronym
Impact of Diabetes Mellitus on Critical Limb Ischemia with Below the Knee Disease
Region
| Japan |
Condition
Condition
Critical limb ischemia
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We studied diabetes effect to critical limb ischemia patients with below the knee lesion alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Limb salvage rate and mortality
Key secondary outcomes
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
Critical limb ischemia patients with below the knee lesion alone
Patients performed endovascular therapy
Key exclusion criteria
Acute arterial occlusive disease
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Suzuki |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular center
Zip code
Address
4-15, Hirosemachi, Aoba-ku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular center
Zip code
Address
TEL
Homepage URL
k-y.suzuki@nifty.com
Sponsor or person
Institute
Sendai Kousei 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
| 2012 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Independent predictor for limb salvage for diabetes are successful revascularization, diabetes control, and infection. Otherwise, only revascularization for non diabetes.
Independent predictos for mortality are ADL, nutrition, and co-morbidity for both groups.
Management information
Registered date
| 2012 | Year | 08 | Month | 23 | Day |
Last modified on
| 2012 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010291
