A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds

NCT00837096 | Terminated Results DMC

• 1 other identifier: VAC 2006-19
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Amputation Foot Wound

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 100% Wound Closure

  Day 84

Study Arms (2)

V.A.C. Therapy

EXPERIMENTAL

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

Moist Wound Therapy (MWT)

ACTIVE COMPARATOR

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)

Interventions

V.A.C. Therapy DEVICE

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.

V.A.C. Therapy

Moist wound therapy (MWT) DEVICE

Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial

Moist Wound Therapy (MWT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KCI USA, Inc: lead

Results Point of Contact

• Title: VP, Global Clinical Affairs
• Organization: Acelity

jane.hart@acelity.com

210-255-5595

Study Officials

• 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 Centre/Research Institute of the McGill University Health Centre

  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

  PRINCIPAL INVESTIGATOR

• Jason Hanft, DPM

  Doctor's Research Network

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 5, 2009
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 16, 2024
• Results First Posted: December 19, 2018

Record last verified: 2024-10