Study of Oasis Ultra in Diabetic Foot Ulcers

A Randomized, Open Label Controlled Trial of OASIS® Ultra Tri-Layer Matrix Compared to Standard Care in the Healing of Diabetic Foot Ulcers

Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra. The hypothesis to be tested is that application of Oasis Ultra will cause more diabetic foot ulcers to heal than wounds treated with regular medical care. Subjects will have their diabetic foot wounds treated for up to 12 weeks with Oasis Ultra or regular medical care .

Inclusion Criteria:

• Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
• Subjects 18 years of age or older of either sex with a history of diabetes mellitus (Type 1 or 2) requiring medication (insulin and/or oral/injectable) to control blood glucose levels.
• A non-healing, Wagner grade 1 or 2, neuropathic diabetic foot ulcer.
• Willing and able to make all required study visits.
• Able to follow instructions.
• An ulcer present on any part of the plantar surface of the foot, which is 0.5 cm2 to 10 cm2 (inclusive), as measured at the Screening Visit prior to debridement, with a duration ≥ 6 weeks (documented in the patient's history or by patient report of onset) but not more than 12 months.
• Separation of at least 5 cm (wound edge to wound edge) if ≥ 2 wounds are present.
• Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of > 40 mmHg OR a transcutaneous oxygen pressure (TcPO2) ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable in lieu of ABI, but if both are obtained, each must meet its respective cutoff.

Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable (test result must be included in the source document).

• Target ulcer is not infected based on clinical assessment.

• Able to perform any required dressing changes at home or have a caregiver who can perform the dressing changes.

• Willing to use an appropriate off-loading device to keep weight off of foot ulcers.

• Blood counts and blood chemistry values as follows:

  • Alanine aminotransferase (ALT) ≤ 3x upper limit of normal
  • Aspartate aminotransferase (AST) ≤ 3x upper limit of normal
  • Serum albumin ≥ 2.0 g/dL •Pre-albumin levels of ≥ 10 mg/dL
  • Alkaline phosphatase ≤ 500 U/L •Serum total bilirubin ≤ 3.0 mg/dL
  • Serum BUN < 75 mg/dL •Serum creatinine ≤ 4.5 mg/dL
  • HbA1c ≤ 12% •Hemoglobin (Hgb) > 8.0 g/dL
  • WBC > 2.0 x 109/L •Absolute neutrophil count > 1.0 x 109/L
  • Platelet count > 50 x 109/L

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the study device or its components (e.g., porcine sensitivity).
• Participation in another investigational study within thirty (30) days of Visit 1 or planned participation overlapping with this study.
• Subjects with evidence of gangrene on either lower limb.
• Ulcers that require negative pressure or hyperbaric oxygen therapy.
• The Medical Monitor may declare any subject ineligible for a valid medical reason.
• Current treatment with disallowed medications or therapies. Subjects may not be enrolled into the study while using systemic antibiotics.