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

Status: Terminated
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Time Frame
Start Date: June 2007
Completion Date: April 2008
Participants
Target number of participants: 19
Treatments
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.
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.
Authors
Vickie Driver, Rodney Stuck, Wyatt Payne, Adam Landsman, Brent Bernstein, Jodi Walters, Thomas Zgonis, Peter Blume, James Mahoney, Christopher Gauland, Kenneth McIntyre, Vivian Halpern, Joseph Whitlark, Christopher Moore, Luis Esquerdo, Marc Corriveau, Stephan Elkouri, John Lantus, Jose Mattei, Lili Moore
Sponsors
Leads: 3M

This content was sourced from clinicaltrials.gov

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