Wound Edge Changes Following Treatment With Santyl

Inclusion Criteria

• •Subjects should be presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies. To improve homogeneity in the group studied, subjects with large wounds, complicated wounds, wounds of long duration, or who have failed multiple attempts at healing in which additional known critical variables were addressed (debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply) will be excluded.
• •Provide written informed consent.
• •Subjects 18 years of age or older, of either sex and of any race, with an existing diagnosis of Type I or Type II Diabetes Mellitus.
• •Presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies but not including therapies generally reserved for chronic wounds (i.e., debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply).
• •Willing to attend all required study visits, and in the opinion of the Investigator, able to properly follow instructions regarding daily dressing changes (dressing changes may be done by a third party, who must agree to perform these daily).
• •Body Mass Index less than or equal to 40
• •A foot wound which meets the following criteria:
• •* Time since initial skin breakdown 56 - 112 days
• •* Wagner† Grade 1
• •* Area between 0.75 and 3.0 cm2, inclusive
• •* Located on plantar surface of midfoot or forefoot, dorsum of foot, or a post-amputation wound
• •* Non-infected based on clinical assessment
• •Adequate blood supply to the affected foot, defined as meeting a transcutaneous oxygen pressure(TcPO2) measured using standard technique and within 4 cm of the wound of greater than or equal to 35 mmHg.
• •Blood chemistry and hematology values as follows, using local lab normal ranges unless otherwise specified:
• •* Blood Glycated Hemoglobin (HbA1C) 6.5 - 10.5%
• •* Blood Glucose less than or equal to 180 mg/dL
• •* Blood Hemoglobin, Hematocrit, Red Blood Cell count within normal limits
• •* Serum Sodium, Potassium, Calcium, Phosphorus, Carbon Dioxide (CO2) within normal limits
• •* Serum Albumin greater than or equal to 2.0 g/dL, serum Pre-Albumin greater than or equal to 15 mg/dL
• •* Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT) less than or equal to 2.0 x Upper Limit of Normal (ULN)
• •* Blood Urea Nitrogen, Total Bilirubin, Creatinine less than or equal to 1.5 x ULN
• •Wound is able to be off-loaded, if indicated. † Wagner Grade 1 = Superficial ulcer, partial or full-thickness, but not involving underlying fat, fascia, tendon, muscle or bone.