Cryopreserved Human Umbilical Cord (TTAX01) for Late Stage, Complex Non-healing Diabetic Foot Ulcers (AMBULATE DFU II)

Exclusion Criteria

• •The subject's index ulcer is primarily located on the dorsal surface of the foot
• •The subject's index ulcer can be addressed by primary closure through the completion of the initial or staged surgical procedure
• •The subject has a contralateral major amputation of the lower extremity
• •The subject has a glycated hemoglobin A1c (HbA1c) level of \> 12% †
• •The subject has been on oral steroid use of \> 7.5 mg daily for greater than seven (7) consecutive days in 30 days before Screening
• •The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening
• •The subject is currently taking the type 2 diabetes medicine canagliflozin (Invokana™, Invokamet™, Invokamet XR™)
• •The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before Screening
• •The subject is pregnant
• •The subject is a nursing mother
• •The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine contraceptive device; or surgical sterilization of partner).
• •The subject is unable to sustain off-loading as defined by the protocol
• •The subject has an allergy to primary or secondary dressing materials used in this trial
• •The subject has an allergy to glycerol
• •The subject's index ulcer is over an acute Charcot deformity
• •The subject has had previous use of NEOX®, CLARIX®, or TTAX01 applied to the index ulcer
• •Per Investigator's discretion the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or the subject currently has sepsis, i.e., life-threatening organ dysfunction caused by a dysregulated host response to infection