ABSTRACT
Historically, outcomes of diabetic foot ulcers (DFUs) have been poor. In a metaanalysis of control groups from randomized clinical trials (RCTs) for DFUs, only 24.2% of wounds that received “standard therapy” healed in 12 weeks (1). However, outcomes may be even worse in clinical practice because the exclusion and inclusion criteria used in RCTs exclude the least desirable and most challenging patients. RCTs that evaluate treatments for DFUs exclude high-risk patients such as those with poor glycated hemoglobin, peripheral arterial disease (PAD), and large, deep, or infected wounds. Most industry-sponsored studies do not reflect the majority of patients who are treated in clinical practice. For instance, Carter et al. (2) used a large electronic medical records database from wound clinics and found that more than half of patients would have been excluded from 15 of 17 RCTs. Most RCTs use less than optimal techniques for “off-loading” the ulcer, such as shoes and healing sandals. In fact, most descriptive cohort studies of total contact casts and RCTs that study off-loading devices have a healing rate that is twice that of “advanced therapies” such as bioengineered tissue, growth factors and negative pressure wound therapy (NWPT) (3,4).
