| Eligibility |
Inclusion Criteria:
- 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
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