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

ID#: NCT04176120

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: July 01, 2020

End Date: April 01, 2023

Contact Information:
Kathleen Ripp
Stanley Harris
Summary: It is hypothesized that application at 4-week or greater intervals of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer (DFU) will, with concomitant management of infection, will result in a higher rate of wounds showing complete healing within 26 weeks of initiating therapy, compared with standard care alone. This confirmatory Phase 3 study examines a population of diabetic foot ulcer patients having adequate perfusion, with or without neuropathy, and a high suspicion of associated osteomyelitis in a complex, high grade wound.

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 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 device (IUD); 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