Intralesional Human Recombinant Epidermal Growth Factor for the Treatment of Advanced Diabetic Foot Ulcer: From Proof of Concept to Confirmation of the Efficacy and Safety of the Procedure

Foot ulceration is among the most significant complications of diabetes. It is estimated that 15% of the diabetic patients develop ulcers at some point in their lives (Reiber, 1996). The therapeutic management of a diabetic patient carrying a diabetic foot ulcer (DFU) is currently based on: metabolic control, debridement (Brem et al., 2004), moist cures, wound dressing, local pressure off-loading, antimicrobial treatment of infections, and revascularization procedures, when indicated. More recent therapies such as topical growth factors (Tsang et al., 2003; Brem et al., 2004; Eldor et al., 2004; Hong et al., 2006; Viswanathan et al., 2006), skin substitutes (Marston et al., 2003; Veves et al., 2001), and others have shown efficacy in pure neuropathic, non-complicated ulcers. However, these products would still have to be tested in advanced lesions including those with an ischemic etiopathogenic component. Still 10 to 30% of the cases progress to amputation, frequently preceded by gangrene and infection (Lipsky, 2004). After amputation of a lower limb, the five year mortality rate reaches 50-60% (Reiber, 1996). Therefore, despite progress in the diagnosis and treatment of infection and other complications (Lipsky, 2004; Williams et al., 2004), the advanced DFU is still an unmet medical need.