UMIN-CTR Clinical Trial

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

Buerger disease

Classification by specialty

Medicine in general	Cardiology	Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

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

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

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

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

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

Institute

Nippon Sigmax Co.

Institute

Department

Personal name

Organization

Nippon Sigmax Co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

08

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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