Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: Santyl; Tegaderm Hydrogel
Intervention description: Apply one 24-hr period sufficient to cover the wound.; Apply once 24-hr period sufficient to cover the wound.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study compares two standard methods for cleaning the surface of wounds on the feet of
      patients with diabetes mellitus. The question being asked is whether inflammation of the
      wound affects the ability of one or both of the methods to work.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The informed consent document must be read, signed, and dated by the subject or the
             subject's legally authorized representative before conducting any study procedures or
             exams. In addition, the informed consent document must be signed and dated by the
             individual who consents the subject before conducting the screening visit. A photocopy
             of the signed informed consent document must be provided to the subject, and the
             original signed document placed in the subject's chart.

          -  Of either sex, aged 18 years or older.

          -  A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood
             glucose levels.

          -  A qualifying ulcer, defined as follows:

               -  Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1)

               -  Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to
                  Section 9.4.2)

               -  Has not been treated or has not responded to treatment during the past 30 days

               -  Has an apparent area ≥ 3.0 cm²

          -  Requires debridement of the wound bed

          -  Is sufficiently moist to allow collection of wound fluid using a filter paper disc

          -  Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤
             1.1; if the ABI is greater than 1.1, then toe pressure of >50 mmHg.

          -  Subject must be willing to use the Darco shoe off-loading device and insole, or a
             comparable device, as indicated.

          -  Subject able to follow instructions, particularly regarding the application of test
             articles and dressings at home. Able to apply the test articles, or has a caregiver
             available to apply the test articles according to the protocol.

        Exclusion Criteria:

          -  Contraindications or known hypersensitivity to the test articles or their components.

          -  Cellulitis extending >2 cm around the target ulcer, lymphangitic streaking, spread
             beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle,
             tendon, joint or bone.

          -  Target ulcer tunneling per probing and visual assessment.

          -  Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol
             within 10 days of SCR visit.

          -  Concomitant illness or condition which, in the opinion of the Principal -
             Investigator, places the subject at risk for this study.

          -  The Medical Monitor may declare any subject ineligible for a valid procedural or
             medical reason.