UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012349 |
|---|---|
| Receipt number | R000014440 |
| Scientific Title | Effects of shock wave therapy to the digital ulcers of Scleroderma |
| Date of disclosure of the study information | 2013/11/19 |
| Last modified on | 2015/12/12 11:39:47 |
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Basic information
Public title
Effects of shock wave therapy to the digital ulcers of Scleroderma
Acronym
Effects of shock wave therapy to the digital ulcers of Scleroderma
Scientific Title
Effects of shock wave therapy to the digital ulcers of Scleroderma
Scientific Title:Acronym
Effects of shock wave therapy to the digital ulcers of Scleroderma
Region
| Japan |
Condition
Condition
Scleroderma
Classification by specialty
| Medicine in general | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the efficacy and safety of ESWT to skin area of fingers, hands, forearms , toes and feet of the patients affected by SSc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The reduction of numbers of ulcers at 8 week.
Key secondary outcomes
The reduction of numbers of ulcers at 4, 12 week.
The reduciton of number of big ulcer (more than 5mm)
The reduction ratio of ulcer at 4, 8, 12 week.
Emergence of new ulcer
Improvement rate of patient's VAS
improvement of HAQ
Improvemnet of EQ5D
Improvement of blood flow measeured by themography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Extracorporeal shock waves therapy
Interventions/Control_2
ordinary treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
age of over 18y/o
SSC diagnosed with ACR criteria
Written informed consent to participate.
Key exclusion criteria
Treated with new drug for ulcer prior 4 weeks.
Patients with sevear heart disease. Patients with infectious disease.
The pregnant and lactating female, female who has possibility of the pregnancy.
Patients who were judged inappropriate to entry this study by physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishii |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
tishii@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
Homepage URL
tishii@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 11 | Month | 19 | 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
| 2013 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2015 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014440
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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