Chronic arterial occlusive disease (arteriosclerosis obliterans or Buerger'
Conditions
Interventions
None listed
Sponsors
AnGes, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic arterial occlusion (arteriosclerosis obliterans and Buerger's disease) who have inadequate response to standard drug therapy and difficulty in undergoing revascularization
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to any component of Collategene. 2) Patients with current or previous malignant tumor in the muscle for injection or its surrounding tissues. 3) Patients with ulcers with exposed bone or tendon or in patients with necrosis. 4) Patients with necrotic tissue extending widely over the lower limb or in patients with life-threatening lower limb infections that cannot be controlled with antimicrobials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete ulcer healing at Week 12 to be compared between Collategene group and control group | — |
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 - Lower limb prognosis and survival in Collategene group - Short- and long-term safety in Collategene group | — |
Countries
Japan
Contacts
Public ContactMitsuaki Chujo
AnGes, Inc. Pharmacovigilance Department
Outcome results
None listed