Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia.
Phase 3
- Conditions
- Peripheral arterial disease
- Registration Number
- JPRN-UMIN000020336
- Lead Sponsor
- Kaneka Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients below SPP 20 mmHg at dorsal or planter of foot with ischemic ulcer 2. Patients with ischemic ulcer above ankle joint 3. Patients with metatarsal osteomyelitis 4. Patients planned to undergo major amputation of any lower limb above lisfranc joint 5. Patients who are unable to refrain from angiotensin converting enzyme inhibitor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of completely healed ischemic ulcer upon to 24 weeks after apheresis therapy
- Secondary Outcome Measures
Name Time Method 1. Time to complete ischemic ulcer healing 2. Granulation formation in ischemic ulcer 3. Changes in skin perfusion pressure at the foot with ischemic ulcer 4. Changes in ankle brachial index 5. Analysis of adverse events