Wound Edge Changes Following Treatment With Santyl
Condition: Diabetic Foot Ulcers; Diabetic Foot Wounds
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Collagenase Santyl Ointment; Placebo Comparator
Intervention description: Topical daily application; Topical daily application
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic; Foot; Ulcers; Wounds

Summary:

      The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds
      following 14 days of treatment with Santyl or its vehicle base.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for the study, subjects must meet the following 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.

        Exclusion Criteria:

        Subjects meeting any of the following criteria during the screening period will be excluded
        from the study:

          -  Contraindications or hypersensitivity to the use of the study medications or their
             components

          -  Therapy with another investigational agent within thirty (30) days of Visit 1.

          -  Calluses or maceration of periwound area which would interfere with successful biopsy
             of the wound edge.

          -  Undermining or tunneling of the target wound.

          -  Evidence of osteomyelitis on screening roentgenogram of the target foot.

          -  Coagulation defect or bleeding disorder which, in the opinion of the Investigator,
             will make the biopsy procedures too risky.

          -  The Medical Monitor may declare any subject ineligible for a valid medical reason.