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)

Tracking Information
First Submitted Date ICMJE	February 3, 2009
First Posted Date ICMJE	February 5, 2009
Last Update Posted Date	October 14, 2013
Study Start Date ICMJE	June 2007
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 22, 2011)	Time required to achieve wound bed preparation [ Time Frame: Day 28, 56, and 84 ]
Original Primary Outcome Measures ICMJE; (submitted: February 4, 2009)	Time required to achieve wound bed preparation
Change History	Complete list of historical versions of study NCT00837096 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 22, 2011)	Incidence of 100% wound closure at 3 different days [ Time Frame: Days 28, 56, and 84 ]; Time required to achieve 100% wound closure [ Time Frame: Day 28, 56, and 84 ]; Incidence of secondary amputations of the study extremity [ Time Frame: Day 28, 56, and 84 ]; Subject reported outcomes (PRO) [ Time Frame: Day 28, 56, and 84 ]; Resource ultilizatoin and cost of care assessed at each study visit [ Time Frame: Day 28, 56, and 84 ]
Original Secondary Outcome Measures ICMJE; (submitted: February 4, 2009)	Incidence of 100% wound closure at 3 different days [ Time Frame: Days 28, 56, and 84 ]; Time required to achieve 100% wound closure; Incidence of secondary amputations of the study extremity; Subject reported outcomes (PRO); Resource ultilizatoin and cost of care assessed at each study visit
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
Official Title ICMJE	A Prospective, Randomized, Multicenter, Parallel Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
Brief Summary	The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation. To determine this, measures of healing, quality of life, and utilization costs associated with this approach will be analyzed. KCI believes that information obtained from this study will show V.A.C. NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective, cost-efficient healthcare solution.
Detailed Description	Primary objective is to compare time required to achieve wound bed preparation between Subjects randomized to receive V.A.C. NPWT or MWT. Subjects with ALL the following are eligible for clinical trial enrollment: Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HbA1C less than or equal to 10%, within 90 days of screen or at time of screening, greater than or equal to 18 years of age, forefoot amputation less than or equal to 10 days old distal to the transmetatarsal level, not extending beyond the Lisfranc joint, receiving MWT allowed in the protocol for treatment of the study wound, Wound surface area measured as length x width of greater than or equal to 10 cm2, Subject is willing and able to provide written informed consent and comply with follow-up visit schedule and maintain a treatment diary, Adequate nutrition to enable wound healing as evidenced by a prealbumin level of greater than or equal to 16 mg/dl or an albumin level of greater than or equal to 3 g/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, Non-pregnant female Subject of childbearing potential confirmed negative by serum HCG or surgically sterilized or unable to conceive.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetic Amputation Foot Wound
Intervention ICMJE	Device: V.A.C. Therapy Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.; Device: Moist wound therapy (MWT) Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
Study Arms	Experimental: V.A.C. Therapy 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. Intervention: Device: V.A.C. Therapy; Active Comparator: Moist Wound Therapy (MWT) 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. Intervention: Device: Moist wound therapy (MWT)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: February 4, 2009)	17
Original Actual Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual Primary Completion Date	April 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00837096
Other Study ID Numbers ICMJE	VAC 2006-19
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	KCI USA, Inc.
Study Sponsor ICMJE	KCI USA, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Peter Blume, DPM, F.A.C.F.A.S North American Center for Limb Preservation Principal Investigator: Brent Bernstein, DPM, F.A.C.F.A.S St. Lukes Allentown & Bethlehem Principal Investigator: Marc Corriveau, M.D. McGill University Health Center Principal Investigator: Vickie Driver, M.D. Boston University Principal Investigator: Stephan Elkouri, MD, MSc, FRCSC, FAC Centre Hospitalierde l'Universite' de Montreal (CHUM) Principal Investigator: Luis Esquerdo, DPM Esquerdo Podiatric Center Principal Investigator: Christopher Gauland, MD Eastern Carolina Foot and Ankle Principal Investigator: Vivian Halpern, MD North Shore University Hospital Study Director: Jason Hanft, DPM Doctor's Research Network Principal Investigator: Adam Landsman, DPM, PhD. Beth Israel Deaconess Medical Center Division of Podiatry, Baker 3 Principal Investigator: John Lantus, MD St. Lukes-Roosevelt Hospital Center Principal Investigator: James Mahoney, MD, FRCS Division of Plastic Surgery- St. Michael's Hospital Principal Investigator: Jose Mattei, MD, DPM CTI Network Inc Principal Investigator: Kenneth McIntyre, MD Mike O'Callaghan Military Hospital Principal Investigator: Christopher Moore, DPM Moore Foot & Ankle Specialists, PA Principal Investigator: Lili Moore, DPM Moore Foot & Ankle Specialists, PA Principal Investigator: Wyatt Payne, MD Bay Pines VAHCS Principal Investigator: Rodney Stuck, DPM Hines VA Hospital Principal Investigator: Jodi Walters, DPM Southern Arizona VA Healthe Care System Principal Investigator: Joseph Whitlark, MD Comprehensive Wound Care, Inc Principal Investigator: Thomas Zgonis, MD University of Texas
PRS Account	KCI USA, Inc.
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP