Buerger disease
Conditions
Interventions
Developed devise, SX-1001 (intervention group)
Dummy-control
Sponsors
Nippon Sigmax Co.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rest pain intensity change on visual analog scale from base line to 24th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoshihiro Nishimura
Nippon Sigmax Co. Department of Development
Outcome results
None listed