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)

This study has been terminated.
(Business objectives changed.)
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT00837096
First received: February 3, 2009
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Diabetic Amputation Foot Wound
Device: V.A.C. Therapy
Device: Moist wound therapy (MWT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • Time required to achieve wound bed preparation [ Time Frame: Day 28, 56, and 84 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of 100% wound closure at 3 different days [ Time Frame: Days 28, 56, and 84 ] [ Designated as safety issue: Yes ]
  • Time required to achieve 100% wound closure [ Time Frame: Day 28, 56, and 84 ] [ Designated as safety issue: Yes ]
  • Incidence of secondary amputations of the study extremity [ Time Frame: Day 28, 56, and 84 ] [ Designated as safety issue: Yes ]
  • Subject reported outcomes (PRO) [ Time Frame: Day 28, 56, and 84 ] [ Designated as safety issue: No ]
  • Resource ultilizatoin and cost of care assessed at each study visit [ Time Frame: Day 28, 56, and 84 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Device: Moist wound therapy (MWT)
Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837096

Sponsors and Collaborators
KCI USA, Inc.
Investigators
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 Federal 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
  More Information

No publications provided

Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT00837096     History of Changes
Other Study ID Numbers: VAC 2006-19
Study First Received: February 3, 2009
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Foot
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Ulcer
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014