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
- Conditions
- Buerger disease
- Registration Number
- JPRN-UMIN000014757
- Lead Sponsor
- ippon Sigmax Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
• 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
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rest pain intensity change on visual analog scale from base line to 24th week
- Secondary Outcome Measures
Name Time Method 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