Santyl vs. Sharp Debridement of Diabetic Foot Wounds
Condition: Diabetic Foot Ulcers; Foot Wounds
MeSH terms: Diabetic Foot; Foot Ulcer; Wounds and Injuries
Intervention: Santyl; Control
Intervention description: 2 mm Santyl applied once daily.; Daily gauze and optional sharp debridement
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcers; Diabetic Foot Wounds

Summary:

      This study tests two different approaches to the removal of dead tissue from the surface of a
      wound.
    

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 Visit 1. 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.

          -  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.

          -  Willing 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 the Darco (orthopedic) shoe off-loading device and insole, if
             appropriate, starting on the day of screening and running through the follow-up phase.

          -  A history of Type I or Type II Diabetes Mellitus requiring insulin or oral
             hypoglycemic medications to normalize blood glucose levels.

        A foot wound which is:

          -  Superficial, involving the full skin thickness but not underlying tissues and is 0.5
             cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided)

          -  Chronic, defined as open for 30 days

          -  On a neuropathic foot, defined as inability to perceive 10 grams pressure using a
             Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area

          -  Adequately perfused, defined as TcPO2 > 40 mmHg; or toe pressure > 40 mmHg, or Doppler
             waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms)
             at screening.

               -  Acceptable state of health and nutrition with:

          -  Serum albumin ≥ 2.0 g/dL (20g/L)

          -  Pre-albumin levels of ≥ 15 mg/dL (0.15g/L).

               -  Per Screening lab chemistry† report:

          -  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 blood urea nitrogen (BUN) < 75 mg/dL

          -  Serum creatinine 4.5 mg/dL

          -  HbA1c 12%

               -  Per Screening lab hematology† report:

          -  Hemoglobin (Hgb) > 8.0 g/dL

          -  White blood cells (WBC) > 2.0 109/L

          -  Absolute neutrophil count > 1.0 109/L

          -  Platelet count > 50 109/L.

               -  Local laboratories will be used, but the ranges for inclusion are set based on
                  Healthpoint Data Management ranges. Refer to Appendix 18.1.2.

        Exclusion Criteria:

          -  Contraindications or hypersensitivity to the use of the study medications or their
             components (refer to product labels).

          -  Target wound does not require debridement, or is covered with dry eschar.

          -  Uncontrolled bleeding disorder.

          -  Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic
             streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or
             infection of muscle, tendon, joint or bone.

          -  Infection in a patient with systemic toxicity or metabolic instability (e.g., fever,
             chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe
             hyperglycemia, or azotemia).

          -  Any of the following:

               -  Target wound tunneling per probing and visual assessment

               -  Osteomyelitis of the target foot or wound probes to bone

               -  Target wound is on the heel

               -  Target wound is over a Charcot deformity which cannot be offloaded.

          -  Diagnosis of chronic granulomatous disease, leukocyte adhesion defects or severe
             neutropenia

          -  Treatment with any of the following:

               -  Systemic corticosteroids

               -  Immunosuppressive agent(s)

               -  Chemotherapeutic agent(s)

               -  Antiviral agent(s)

               -  Platelet-derived growth factor

               -  Living skin equivalent

               -  Dermal substitute

               -  Radiation therapy to the target lower extremity within 30 days prior to signing
                  the informed consent document.

               -  Currently on systemic antibiotic therapy

          -  Any medical condition judged by the Medical Monitor and/or Investigator to cause the
             study to be detrimental to the subject (specify on the reason for screen failure if
             this applies).