Abstract

Over the last few years, substantial advances have been made in our understanding of the pathophysiology of diabetic foot ulcers, the importance of thorough surgical debridement, and how this standard therapeutic modality impacts on wound bed preparation (WBP). Importantly, the concept of WBP is revolutionizing the way we approach nonhealing or difficult to heal wounds, including those due to diabetes. Much of what we do clinically, from elimination of bacterial burden, to debridement, and to the use of new technologies to heal diabetic foot ulcers, can now be seen as being part of the comprehensive WBP strategy and as facilitating the process of healing [Falanga Wound Repair Regen 8:347–52, 2000; Falanga et al. Ostomy Wound Manage Suppl:2–13, 2008]. From a therapeutic standpoint, at least in the USA, large multicenter clinical trials have led to the regulatory approval for neuropathic diabetic ulcers of topically applied platelet-derived growth factor (PDGF) BB (beclapermin or Regranex, Ortho-McNeil, Raritan, NJ) (Smiell et al. Wound Repair Regen. 7:335–46, 1999; Steed J Vasc Surg 21:71–8, 1995; Steed et al. J Am Coll Surg 183:61–4, 1996) and living bioengineered skin [Apligraf, Organogenesis, Canton, MA (Falanga Lancet 366:1736–43, 2005; Lazic and Falanga Plast Reconstr Surg 127 Suppl 1:75S–90, 2011; Veves Plast Reconstr Surg 127 Suppl 1:91S–2, 2011; Veves et al. Diabetes Care 24:290–5, 2001); and Dermagraft, Advanced Biohealing, La Jolla, CA (Marston et al. Diabetes Care 26:1701–5, 2003)], and have dramatically increased the number of available therapeutic options. However, not to be forgotten are advances that these and other clinical trials have brought to the standard of care for treating neuropathic diabetic foot ulcers. Indeed, these improvements in standards of care for diabetic foot ulcers have raised the bar for proving the effectiveness of new treatments. Stated differently, it may have become harder to prove the effectiveness of new therapeutic agents. Thus, from now on we may be looking for “quantum” jumps in therapeutic efficacy in the treatment of diabetic foot ulcers.

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