UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011886 |
|---|---|
| Receipt number | R000013893 |
| Scientific Title | Effects of shock wave therapy to the digital ulcers of Scleroderma,Lupus erythematodes and Mixed connective tissue disease a pilot study |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2014/07/03 15:09:44 |
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Basic information
Public title
Effects of shock wave therapy to the digital ulcers of Scleroderma,Lupus erythematodes and Mixed connective tissue disease
a pilot study
Acronym
Effects of shock wave therapy to the digital ulcers of Scleroderma,Lupus erythematodes and Mixed connective tissue disease
a pilot study
Scientific Title
Effects of shock wave therapy to the digital ulcers of Scleroderma,Lupus erythematodes and Mixed connective tissue disease
a pilot study
Scientific Title:Acronym
Effects of shock wave therapy to the digital ulcers of Scleroderma,Lupus erythematodes and Mixed connective tissue disease
a pilot study
Region
| Japan |
Condition
Condition
Scleroderma,Lupus erythematodes and Mixed connective tissue disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assece the efficasy and safety of ESWT skin application to patients affected by SSc, SLE and MCTD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number and size of ulcers at 20W.
Key secondary outcomes
VAS,HAQ,EQ5D,Painvision,Skin Score and temperature of fingers at 20W
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
| Device,equipment |
Interventions/Control_1
Energy 0.08~0.25mJ/mm2
Frequency4Hz
200shots along the dorsal side of each fingers
500 shots at both hands
500 shots along the both volar forearm
200 shots along the underside each toes
500 shots along the sole of the feet
Total 7000 shots
1 sitting/week X9
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
Over20
Patients of SSc, SLE, MCTD with new digital ulcers
Key exclusion criteria
who does not give informed consent
who has severe heart or lung complication whose ulcer is infected
pregnant or lactataing or expecting pregnancy during the study
under other clinical study
ETC
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishii |
Organization
Tohoku university Hospital
Division name
Dep of Hematology and Rheumatology
Zip code
Address
1-1 Seiryo Aobaku Sendai
TEL
022-717-7165
tishii@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Saito |
Organization
Tonoku University Hospital
Division name
Dep of Hematology and Rheumatolog
Zip code
Address
1-1 Seiryo Aobaku Sendai
TEL
022-717-7165
Homepage URL
saitos01@yahoo.co.jp
Sponsor or person
Institute
Dep of Hematoogy and Rheumatolog
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant Aid from Ministry of health, labour and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 27 | 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
The present study demonstrates that, in patients affected by SSc, skin application of ESW causes a rapid and persistent improvement of clinical parameters (RSS and VAS for skin wellness) Our results showed both a short-term and a long-term effect of ESW:
we observed a rapid improvement of skin elasticity as measured by RSS and VAS, with a persistent effect during the time (until 30 days after the treatment for RSS
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013893
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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