Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease

Inclusion Criteria: * Willing and able to provide informed consent and capable of understanding and complying with the protocol; * Subjects classified as critical limb ischemia (CLI) Rutherford Category 2 or 3 (moderate or severe) claudication; * Diabetes mellitus type 2 with HbA1c \< 9%; * In case of treatment for PAD, the subject is controlled on medical therapy indicated for CLI; * A female patient is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use a highly effective method of contraception; * A male patient with a female partner of childbearing potential is eligible if he agrees to use acceptable method of contraception. Exclusion Criteria: * Planned surgical or endovascular revascularization on the index leg within the next 12 months; * Failed surgical or endovascular revascularization on the index leg within 10 days prior to screening; * Amputation at or above the talus on the index leg; * Planned major amputation within the first month after screening; * On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new treatments to the index leg during the trial; * Uncontrolled or untreated proliferative retinopathy; * Blood clotting disorder not caused by medication; * Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; * Evidence of moderate to se…