Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
Condition: Non-healing Wound; Non-healing Diabetic Foot Ulcer; Diabetic Foot Infection
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: TTAX01; Surgical resection and debridement; Systemic antibiotics; Off-loading
Intervention description: TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.; Perform surgical sharp debridement in the OR, to remove:
infectious agents and biofilms (purulence),
all debris, eschar, callus and macerated non-viable tissue from the wound base, and
dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.
Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate.; Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.; Provide off-loading device appropriate to the location of wound with full length boot or total contact cast
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to
      the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management
      of infection, result in a higher proportion of wounds showing complete healing within 16
      weeks of initiating therapy.
    

Eligibility criteria:

        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, or
             lateral or medial surface of the foot

          -  The subject has an index ulcer with visible margins having an area ≥1.0 cm2 to ≤ 10.0
             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 Ankle Brachial Index ≥ 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

        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 glycated hemoglobin A1c (HbA1c) level of > 12%

          -  The subject has a serum albumin level ≤ 2.0 g/dL

          -  The subject has a white blood cell count < 2.0 x109/L, neutrophils < 1.0 x109/L, or
             platelets < 100 x109/L

          -  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's index ulcer is over an active 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