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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014757
Receipt No. 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

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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 &#8226; Planned major amputation during study period
&#8226; Possibility of successful by-pass surgery or catheter treatment on the index leg
&#8226; Applicability of by-pass surgery or catheter treatment on the index leg
&#8226; Active malignant disease, severe malfunction of liver or kidney ng the forefoot evidenced by imaging (radiography)
&#8226; Not expected to survive more than 12 months, in the opinion of a principal investigator of the study site
&#8226; A history of malignant disease or previous or present history of cardiac infarction or stroke within 3 months before recruitment.
&#8226; Cardiovascular diseases of New York Heart Association (NYHA) class III or IV or active angina
&#8226; Women present or planned pregnant during the study period
&#8226; Previous treatment with other investigational clinical trial within 6 months before recruitment
&#8226; 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
Email 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
Email y_nishimura@sigmax.co.jp

Sponsor
Institute Nippon Sigmax Co.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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