Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment
- Conditions
- Chronic arterial occlusive disease (arteriosclerosis obliterans or Buerger's disease)
- Registration Number
- JPRN-UMIN000044964
- Lead Sponsor
- AnGes, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 82
Not provided
1) Patients with ulcers that expose bone or tendon, or gangrene, in the target or contralateral limb 2) Patients with extensive necrotic tissue or a life-threatening infection uncontrolled by antibiotics in the lower limb 3) Patients with current evidence or a history of malignant neoplasm in the target limb 4) Patients who underwent revascularization of the target limb within 4 weeks prior to registration However, this shall not apply if ischemia persists or is confirmed by an objective measure. 5) Patients with ischemic symptoms due to acute arterial occlusion in the target limb within 4 weeks prior to registration 6) Patients who are scheduled to undergo revascularization of the target limb within 12 weeks after registration 7) Patients who received Collategene 8) Patients who received angiogenic therapy other than Collategene or vascular regeneration therapy within 6 months prior to registration 9) Patients who previously participated in the investigation as a control patient 10) Other patients who, in the opinion of the investigator, are ineligible for the investigation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method