The worldwide increase in prevalence of
type 2 diabetes has resulted in a parallel increase in
diabetic foot ulcers--a pervasive and significant problem associated with this disease [2]. Currently, an estimated 10.3 million people have been diagnosed with diabetes, while an additional estimated 5.4 million people with diabetes remain undiagnosed, representing a sixfold increase in the incidence of diabetes over the past four decades [9]. Approximately 15% (more than 2 million individuals, based on these estimates) of all people with diabetes will develop a lower-extremity
ulcer during the course of the disease [10-12]. While most of these
ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Ultimately, between 14% and 20% of patients with lower-extremity diabetic
ulcers will require
amputation of the affected limb [13-15].
Diabetic foot ulcers can result in staggering financial burdens for both the healthcare system and the patient. For example, analysis of the 1995 Medicare claims revealed that lower-extremity
ulcer care accounted for $1.45 billion in Medicare costs and contributed substantially to the high cost of care for diabetics, compared with Medicare costs for the general population [5].
Therapies that promote rapid and complete healing and reduce the need for expensive
surgical procedures would impact these costs substantially. Results of this analysis suggest that
becaplermin may ultimately be more cost-effective for the treatment of chronic
diabetic foot ulcers than other treatment modalities, despite its higher initial dollar cost. This finding may be attributed to a combination of factors. First, expenses incurred in more prolonged treatment, such as office visits and the need for additional dressings, can be avoided when healing completes in a shorter period. Second, rapid and complete
ulcer healing may reduce the incidence of significant morbidities (such as
amputation or
infection) and premature mortality; consequently, the financial burden associated with these complications would be reduced. Finally, the value of improved quality of life in patients with healed
ulcers and the reduction in financial burden for patients who return to work cannot be ignored. These promising results warrant further investigation in larger controlled clinical studies to define more clearly the cost-effectiveness of
becaplermin in this patient population.