Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

Inclusion Criteria:

• Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1,

• A single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity withoutevidence of infection or gangrene and no evidence of bone and/or tendon involvement atrandomization
• Subjects will undergo protocol-defined standardized wound care during the screeningperiod and through 12 months from the first dose of investigational product
• Subjects who have a diagnosis of diabetes must be considered stable with no changes indiabetic medication regimen anticipated during the study period. Subjects who have adiagnosis of diabetes must have a HbA1c of ≤12% at Screening

Exclusion Criteria:

• Subjects who have excessive tissue necrosis that is unlikely to benefit frommedication, or those subjects who, in the opinion of the Investigator, are felt likelyto require revascularization within 1 month of screening
• Subjects with severe limb ischemia
• Subjects who are considered likely to require a major amputation (at or above theankle) within 3 months of screening
• Subjects with deep ulcerations with bone or tendon exposure, or uncontrolledinfection, or with the largest ulcer that is >10 cm2 in area
• Subjects with hemodynamically significant aorto-iliac occlusive disease
• Subjects who have had a technically successful revascularization by surgery orangioplasty within 2 months. If subjects are more than two months fromrevascularization and still meet the inclusion criteria, they may be considered forenrollment. Subjects who have had a technically unsuccessful attempt atrevascularization may be enrolled at least one week from the procedure
• Subjects currently receiving immunosuppressive medication, systematically administeredsteroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroidtherapies are allowed