Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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