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

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 of Screening * 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 when measured by the electronic measuring device at Screening * The subject's index ulcer extends beyond the dermis, into subcutaneous tissue with evidence of exposed bone, tendon, muscle and/or joint capsule * The subject presents with history, signs or symptoms leading to a clinical suspicion of osteomyelitis in the opinion of the Investigator supported by positive Probe to Bone (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 ABI ≥ 0.7 to ≤ 1.3 or TcPO2 ≥ 40 mmHg on the dorsum 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 thr…