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A Pilot Randomized Study of the Treatment of Diabetic Foot Ulcers with a Bioactive CoPolymer, E‐Matrix
Author(s) -
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.
Publication year - 2008
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2005.130215ag.x
Subject(s) - medicine , randomized controlled trial , clinical endpoint , surgery , adverse effect , debridement (dental) , wound healing , diabetic foot , clinical trial , matrix (chemical analysis) , wound care , diabetes mellitus , materials science , composite material , endocrinology
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 cm 2 ) and older (>17 weeks duration) wounds (see table).Parameter Treatment Group N Closed %ClosedSize >2 cm E‐Matrix 17 8 47%Control 14 4 29% Ulcer duration >17 weeks E‐Matrix 15 6 40%Control 15 3 20%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.