Using Santyl on Diabetic Foot Ulcers

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. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
• •A target ulcer which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 30 days (documented in the patient's history or by patient report of onset) which requires sharp surgical debridement.
• •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 TcPO2 ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable as a stand-alone measurement, 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.
• •A target ulcer that is not infected based on clinical assessment.
• •Willing and able to make all required study visits.
• •Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
• •Willing to use an appropriate off-loading device whenever necessary to keep weight off of any foot ulcers.
• •History of diabetes mellitus (Type 1 or 2) requiring insulin or oral hypoglycemic medications to control blood glucose levels.
• •CBC and blood chemistry values as follows:
• •* Serum albumin ≥ 2.0 g/dL
• •* Pre-albumin levels of ≥ 15 mg/dL
• •* Alkaline phosphatase ≤ 500 U/L
• •* Alanine aminotransferase (ALT) ≤ 200 U/L
• •* Aspartate aminotransferase (AST) ≤ 175 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