033 A Pilot Randomized Study of the Treatment of Diabetic Foot Ulcers with a Bioactive CoPolymer, E-Matrix
Marston, W.A. ; Blume, P.A. ; Dardik, P. ; Gordon, I. ; Hanft, J.R. ; Hill, R.S. ; Landsman, A.I. ; Lipkin, S. ; Morgan, J. ; Orgill, D. ; Tallis, A.
Oxford, UK; Malden, USA : Blackwell Publishing Ltd/Inc.
Published 2005
Oxford, UK; Malden, USA : Blackwell Publishing Ltd/Inc.
Published 2005
| ISSN: |
1524-475X
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| Source: |
Blackwell Publishing Journal Backfiles 1879-2005
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| Topics: |
Medicine
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| Notes: |
A novel biopolymer composed of porcine gelatin and dextran was used in a randomized controlled pilot clinical trial to treat diabetic foot ulcers to establish safety profile and evaluate effect on wound closure. Fifty-six patients were prospectively randomized at 10 centers (control = 25; E-Matrix = 31). Control patients received routine sharp debridement, off-loading, and hydrogel dressings applied daily. E-Matrix patients received identical wound care with the addition of monthly subcutaneous injections of E-Matrix under the wound surface. Patients were monitored for 12 weeks using wound planimetry and photography. Primary endpoint was safety as measured by adverse event reporting and clinical laboratory analysis. Secondary endpoint was wound closure based on intent to treat.There was no significant difference in the rate of adverse events between treated and control subjects. Overall closure rate for E-Matrix treated wounds was 42%(13 of 31 subjects) compared to 32%(8 of 25 subjects) for controls. Subgroup analysis suggested that E-Matrix may be more effective than control for treatment of larger (〉2 cm2) and older (〉17 weeks duration) wounds (see table).〈table frame="topbot"〉〈tgroup cols="5" align="left"〉〈colspec colnum="1" colname="col1" align="left"/〉〈colspec colnum="2" colname="col2" align="left"/〉〈colspec colnum="3" colname="col3" align="center"/〉〈colspec colnum="4" colname="col4" align="center"/〉〈colspec colnum="5" colname="col5" align="center"/〉〈thead valign="bottom"〉〈row rowsep="1"〉ParameterTreatment GroupNClosed%Closed〈tbody valign="top"〉Size 〉2 cmE-Matrix17847%Control14429%Ulcer duration 〉17 weeksE-Matrix15640%Control15320% Although the study is insufficiently powered to evaluate statistical significance, E-Matrix demonstrated a similar safety profile to control treatment with trends toward improved healing in larger and older wounds. Further randomized trials are necessary to confirm these promising initial results.
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| Type of Medium: |
Electronic Resource
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| URL: |