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

NCT ID: NCT00837096

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Diabetic Amputation Foot Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

V.A.C. Therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Moist wound therapy (MWT)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Moist wound therapy (MWT)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCI USA, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Blume, DPM, F.A.C.F.A.S

Role: PRINCIPAL_INVESTIGATOR

North American Center for Limb Preservation

Brent Bernstein, DPM, F.A.C.F.A.S

Role: PRINCIPAL_INVESTIGATOR

St. Lukes Allentown & Bethlehem

Marc Corriveau, M.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Vickie Driver, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Stephan Elkouri, MD, MSc, FRCSC, FAC

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalierde l'Universite' de Montreal (CHUM)

Luis Esquerdo, DPM

Role: PRINCIPAL_INVESTIGATOR

Esquerdo Podiatric Center

Christopher Gauland, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Carolina Foot and Ankle

Vivian Halpern, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital

Jason Hanft, DPM

Role: STUDY_DIRECTOR

Doctor's Research Network

Adam Landsman, DPM, PhD.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center Division of Podiatry, Baker 3

John Lantus, MD

Role: PRINCIPAL_INVESTIGATOR

St. Lukes-Roosevelt Hospital Center

James Mahoney, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Division of Plastic Surgery- St. Michael's Hospital

Jose Mattei, MD, DPM

Role: PRINCIPAL_INVESTIGATOR

CTI Network Inc

Kenneth McIntyre, MD

Role: PRINCIPAL_INVESTIGATOR

Mike O'Callaghan Military Hospital

Christopher Moore, DPM

Role: PRINCIPAL_INVESTIGATOR

Moore Foot & Ankle Specialists, PA

Lili Moore, DPM

Role: PRINCIPAL_INVESTIGATOR

Moore Foot & Ankle Specialists, PA

Wyatt Payne, MD

Role: PRINCIPAL_INVESTIGATOR

Bay Pines VAHCS

Rodney Stuck, DPM

Role: PRINCIPAL_INVESTIGATOR

Hines VA Hospital

Jodi Walters, DPM

Role: PRINCIPAL_INVESTIGATOR

Southern Arizona VA Healthe Care System

Joseph Whitlark, MD

Role: PRINCIPAL_INVESTIGATOR

Comprehensive Wound Care, Inc

Thomas Zgonis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Other Identifiers

VAC 2006-19

Identifier Type: -

Identifier Source: org_study_id