Beyond the Monofilament for the Insensate Diabetic Foot

A systematic review of randomized trials to prevent the occurrence of plantar foot ulcers in patients with diabetes

  1. Aaron Vinik, MD4
  1. 1Tiara Pharmaceuticals, Los Altos, California
  2. 2Tulane University School of Medicine, Department of Endocrinology, New Orleans, Louisiana
  3. 3Keck School of Medicine-University of Southern California, Department of Endocrinology, Los Angeles, California
  4. 4Eastern Virginia Medical School, Department of Endocrinology, Norfolk, Virginia
  1. Corresponding author: Yadon Arad, yadonarad{at}

Foot ulcers in patients with diabetes lead to infections, amputations, and high costs, and their prevention is a stated goal of the American Diabetes Association. To assess the benefits of various interventions on the prevention of future diabetic foot ulcers, we searched for and reviewed all randomized clinical trials (RCTs) on the prevention of diabetic foot ulcers and evaluated their efficacy and scientific validity on the basis of an established systemic grading system. Only 13 RCTs were identified. All involved secondary prevention or a mixture of primary and secondary prevention. Most were small and of poor quality, with negative studies generally being of better quality than positive studies. Of all methods proposed to prevent diabetic foot ulcers, only foot temperature-guided avoidance therapy was found beneficial in RCTs, although this needs to be validated in other populations. These observations only apply to high-risk populations, and the benefits to the general population with diabetes are unclear.


Diabetic foot ulcers are the cause of immense suffering and health system costs (1). The lifetime risk of a person with diabetes developing a foot ulcer may be as high as 25%, whereas the annual incidence of foot ulcers is as high as 2% (26). Multiple component causes, including peripheral neuropathy, peripheral vascular disease (PVD), foot deformity, and smoking, interact in the causal pathway to foot ulceration. In several cross-sectional and retrospective studies, the prevalence of PVD and peripheral neuropathy in patients was found to be as high as 40%. However, no prospective study clearly documented their relative contribution. This review is concerned primarily with clinical trials on the prevention of foot ulcers in the neuropathic, or insensate, foot.

Several physiologic measurements of the presence and degree of peripheral neuropathy have been shown to be predictive of the risk of future foot ulcer in …

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