UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014757 |
|---|---|
| Receipt number | R000017156 |
| Scientific Title | Effect of Non-invasive Multi Transducer Low-intensity Pulsed Ultrasound, SX-1001, on Clinical Symptoms in Buerger Disease with Critical Limb Ischemia: A Multicentre, Double-blind, Parallel Randomized Clinical Trial |
| Date of disclosure of the study information | 2014/08/07 |
| Last modified on | 2014/08/04 15:16:00 |
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Basic information
Public title
Effect of Non-invasive Multi Transducer Low-intensity Pulsed Ultrasound, SX-1001, on Clinical Symptoms in Buerger Disease with Critical Limb Ischemia: A Multicentre, Double-blind, Parallel Randomized Clinical Trial
Acronym
PUS Study
Scientific Title
Effect of Non-invasive Multi Transducer Low-intensity Pulsed Ultrasound, SX-1001, on Clinical Symptoms in Buerger Disease with Critical Limb Ischemia: A Multicentre, Double-blind, Parallel Randomized Clinical Trial
Scientific Title:Acronym
PUS Study
Region
| Japan |
Condition
Condition
Buerger disease
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study with pulsed ultrasound device, SX-1001, aims to test whether SX-1001 could mitigate rest pain and improve blood supply to ischemic legs of patients with Buerger disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Rest pain intensity change on visual analog scale from base line to 24th week
Key secondary outcomes
Change of rest pain intensity on visual analog scale from base line to 12th week, change of transcutaneous oxygen pressure (TcPO2), skin perfusion pressure (SPP), ankle brachial pressure index (ABI), toe brachial pressure index (TBI) or walking distance from base line to 12th and 24th week, and change of symptoms relating burger disease in the study period of 24 weeks
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Developed devise, SX-1001 (intervention group)
Interventions/Control_2
Dummy-control
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Meet the diagnosis criterion for the specified and intractable vasculitic disease study group of the Ministry of Health and Welfare
Signed informed consent
Limb ischaemia of Fontaine stage III ischaemic ulcers in lower limb
Non-smoking during study period confirmed by plasma cotinine level
Non-improvement of the symptom of Buerger disease with conventional therapy recommended by Trans-Atlantic Inter-Society Concensus (TASC) II
Outpatient visit during 24 week of treatment
Key exclusion criteria
• Planned major amputation during study period
• Possibility of successful by-pass surgery or catheter treatment on the index leg
• Applicability of by-pass surgery or catheter treatment on the index leg
• Active malignant disease, severe malfunction of liver or kidney ng the forefoot evidenced by imaging (radiography)
• Not expected to survive more than 12 months, in the opinion of a principal investigator of the study site
• A history of malignant disease or previous or present history of cardiac infarction or stroke within 3 months before recruitment.
• Cardiovascular diseases of New York Heart Association (NYHA) class III or IV or active angina
• Women present or planned pregnant during the study period
• Previous treatment with other investigational clinical trial within 6 months before recruitment
• Heavy second-hand tobacco smoke or patients excluded by the opinion of the principal investigator of the study site
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Machida |
Organization
Nippon Sigmax Co.
Division name
Department of Development
Zip code
Address
6-8-1 Nishisinjyuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5326-3270
y_machida@sigmax.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishimura |
Organization
Nippon Sigmax Co.
Division name
Department of Development
Zip code
Address
6-8-1 Nishisinjyuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5326-3270
Homepage URL
y_nishimura@sigmax.co.jp
Sponsor or person
Institute
Nippon Sigmax Co.
Institute
Department
Personal name
Funding Source
Organization
Nippon Sigmax Co.
Organization
Division
Category of Funding Organization
Profit 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
| 2014 | Year | 08 | Month | 07 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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
| 2014 | Year | 08 | Month | 04 | Day |
Last modified on
| 2014 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017156
