Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture-controlling smart dressing: a randomized, multicenter, prospective analysis

Abstract

Background: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound.

Methods: This prospective, randomized, multicenter study examined outcomes from treatment of diabetic foot ulcers with TheraGauze and TheraGauze in conjunction with becaplermin. We also compared these outcomes with historical data from the literature that used saline-moistened gauze and becaplermin.

Results: The rates of wound closure with TheraGauze and TheraGauze + becaplermin were 0.37 and 0.41 cm(2)/week, respectively (P = .34). The difference between these values was not statistically significant. We also observed high closure rates at 12 weeks (46.2% in both groups) and 20 weeks (61.5% with TheraGauze alone and 69.2% with TheraGauze + becaplermin). These data were also compared with historical data for closure rates (0.18 cm(2)/week) and percentage of wounds closed using saline-moistened gauze alone and becaplermin with saline-moistened gauze (0.24 cm(2)/week) from a variety of studies.

Conclusions: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used.