A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds (VAC 2006-19)
Diabetic Amputation Foot Wound
About this trial
This is an interventional treatment trial for Diabetic Amputation Foot Wound
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
V.A.C. Therapy
Moist Wound Therapy (MWT)
Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.
t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air.