A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds

• Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HgbA1C ≤10%, within 90 days of screening or at time of screening
• ≥18 years of age
• Forefoot amputation ≤ 8 days old distal to the transmetatarsal level, not extending beyond the Lisfranc's joint
• Receiving MWT allowed in the protocol for treatment of the study wound Protocol: V.A.C. 2006-19 Version 1.10 14 November 2007 Confidential/Proprietary Property of KCI, Inc. 28
• Wound surface area, measured as length x width, of ≥10 cm2
• Subject is willing and able to provide written informed consent, comply with follow-up visit schedule, and maintain a treatment diary

• Adequate nutrition to enable wound healing as evidenced by a pre-albumin level of

  ≥16 mg/dl or an albumin level of ≥3g/dl within 7 days of screening or at the screening visit

• Adequate perfusion in the affected extremity as evidenced by Grade 1 or 2 PVR waveform as confirmed at screening (see Section 7.1)
• Non-pregnant female Subject of child-bearing potential (confirmed negative by serum hCG), surgically sterilized, or unable to conceive

Exclusion Criteria:

• Untreated or refractory cellulitis of the wound with periwound erythema ≥3 cm
• Untreated or refractory osteomyelitis of the wound
• Untreated or refractory infection of the wound
• Exposed blood vessels in or around the wound
• Surgical revascularization of the affected extremity ≤10 days from study enrollment other than by percutaneous means
• Percutaneous revascularization of the affected extremity ≤2 days from study enrollment
• Grade 3-5 PVR waveforms
• Long-term (≥30 days) use of steroids (NOTE: Use of non-wound-indicated topical, optical or aerosol types of steroids are permitted at screening and throughout the clinical trial)
• Active Charcot disease of either lower extremity that will interfere with wound treatment
• Malignancy in the wound, around margins or any other malignancy requiring immunosuppressant therapy or chemotherapy
• Presence of necrotic tissue with eschar or slough that cannot be debrided
• Persistent periwound maceration of >96 hours
• Inadequate wound hemostasis that might impair wound healing
• Reported alcohol or drug abuse within the past 6 months
• Topical hypersensitivity or allergy to any disposable component of the V.A.C.® Protocol: V.A.C. 2006-19 Version 1.10 14 November 2007 Confidential/Proprietary Property of KCI, Inc. 29 NPWT System or to tape, dressings, or adhesives
• Female patients with plans to become pregnant during the study period
• Physical (i.e., venous sclerosis) or mental inability to undergo venipuncture for laboratory specimen collection
• Previous participation in this clinical study (VAC 2006-19)
• Participation in any other clinical study ≤30 days of enrollment
• Severe skin conditions (e.g. Meleney's ulcer, scleroderma) that may impair wound healing
• Connective tissue disease or collagen vascular disease (e.g. Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis) that may impair wound healing
• Hematological disorders or conditions (e.g. polycythemia vera, thrombocythemia, sickle-cell disease) that may impair wound healing
• History of clinically significant chronic anemia as evidenced by a hemoglobin concentration of \<10.0 g/dL within ≤30 days of screening
• Severe venous insufficiency (with or without the presence of venous leg ulcers) that may impair wound healing
• Use of V.A.C.® NPWT System to the study wound ≤8 days prior to screening
• Use of any other suction device on the study wound within ≤8 days prior to screening
• Use of normothermic therapy (Warm-UP®) ≤8 days prior to screening
• Use of hyperbaric oxygen therapy (HBO) ≤30 days prior to screening
• Application of recombinant or autologous growth factors (e.g. Regranex® or Procuren®) on the study wound ≤8 days prior to screening
• Application of skin or dermal substitutes and dressings with living cells capable of producing growth factors (e.g. Oasis®, Apligraf®, Dermagraft