Chronic arterial occlusive disease (arteriosclerosis obliterans or Buerger'
Conditions
Interventions
None listed
Sponsors
AnGes, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged =>20 years 2) Patients with ischemia due to hematogenous disorder confirmed with objective measures in the target limb 3) Patients with clinical symptoms of ulcers caused by lower limb ischemia due to lower limb arterial occlusion or stenosis in the target limb 4) Patients in whom ulcer size in the target limb can be measured 5) Patients who have inadequate response to standard drug therapy and difficulty in undergoing revascularization for the target limb
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete ulcer healing at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in ulcer size at Week 12 - Total number of ulcers and summation of ulcers in the index limb at Week 12 - Change in hemodynamic parameters in the index limb at Week 12 | — |
Countries
Japan
Contacts
Public ContactMitsuaki Chujo
AnGes, Inc. Pharmacovigilance Department
Outcome results
None listed