Clinical trial NCT00837096: 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: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Amputation Foot Wound
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With 100% Wound Closure
timeFrame: Day 84
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: North American Center for Limb Preservation
name: Peter Blume, DPM, F.A.C.F.A.S
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Lukes Allentown & Bethlehem
name: Brent Bernstein, DPM, F.A.C.F.A.S
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Marc Corriveau, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Vickie Driver, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalierde l'Universite' de Montreal (CHUM)
name: Stephan Elkouri, MD, MSc, FRCSC, FAC
role: PRINCIPAL_INVESTIGATOR
affiliation: Esquerdo Podiatric Center
name: Luis Esquerdo, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Carolina Foot and Ankle
name: Christopher Gauland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore University Hospital
name: Vivian Halpern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctor's Research Network
name: Jason Hanft, DPM
role: STUDY_DIRECTOR
affiliation: Beth Israel Deaconess Medical Center Division of Podiatry, Baker 3
name: Adam Landsman, DPM, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Lukes-Roosevelt Hospital Center
name: John Lantus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Plastic Surgery- St. Michael's Hospital
name: James Mahoney, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: CTI Network Inc
name: Jose Mattei, MD, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Mike O'Callaghan Military Hospital
name: Kenneth McIntyre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moore Foot & Ankle Specialists, PA
name: Christopher Moore, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Moore Foot & Ankle Specialists, PA
name: Lili Moore, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Bay Pines VAHCS
name: Wyatt Payne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hines VA Hospital
name: Rodney Stuck, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Arizona VA Healthe Care System
name: Jodi Walters, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Wound Care, Inc
name: Joseph Whitlark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Thomas Zgonis, MD
role: PRINCIPAL_INVESTIGATOR
References: