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

Inclusion Criteria:

• The subject has signed the informed consent form

• The subject is male or female, at least 18 years of age inclusive at the date ofScreening

• The subject has confirmed diagnosis of Type I or Type II diabetes

• The subject's index ulcer is located on the plantar surface, inter digital, heel,lateral or medial surface of the foot

• The subject has an index ulcer with visible margins having an area ≤ 12.0 cm2 whenmeasured by the electronic measuring device at Screening

• The subject's index ulcer extends beyond the dermis, into subcutaneous tissue withevidence of exposed bone, tendon, muscle and/or joint capsule

• The subject presents with history, signs or symptoms leading to a clinical suspicionof osteomyelitis in the opinion of the Investigator supported by positive Probe toBone (PTB) and any of the following: radiographic (X-ray, Magnetic Resonance Imaging (MRI), or bone scan) or evidence of bone necrosis

• The subject has an Ankle-Brachial Index ≥ 0.7 to ≤ 1.3 or TcPO2 ≥ 40 mmHg on thedorsum of the affected foot, or Great Toe Pressure ≥ 50 mmHg

• The subject is under the care of a physician for the management of Diabetes Mellitus

• The subject is willing to return for all mandatory visits as defined in the protocol

• The subject is willing to follow the instructions of the trial Investigator

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 completionof 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 forseven 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 skincancer, 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 avoidpregnancy or use an appropriate form of birth control (adequate birth controlmethods are defined as: topical, oral, implantable, or injectable contraceptives;spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterinecontraceptive 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 thistrial

• 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 indexulcer

• Per Investigator's discretion the subject is not appropriate for inclusion in thetrial, e.g., undergoing surgical treatments listed in the protocol or the subjectcurrently has sepsis, i.e., life-threatening organ dysfunction caused by adysregulated host response to infection