Trials in Neuropathic Diabetic Foot Ulceration
Time for a paradigm shift?
- Andrew J. M. Boulton, MD, FRCP12 and
- David G. Armstrong, DPM23
- 1Division of Endocrinology, Metabolism and Diabetes, University of Miami School of Medicine, Miami, Florida
- 2Department of Medicine, Manchester Royal Infirmary, Manchester, U.K
- 3Department of Surgery, Southern Arizona Veterans Affairs Medical Center, Tucson, Arizona
- Address correspondence to Andrew J.M. Boulton, MD, FRCP, Division of Endocrinology, University of Miami School of Medicine, PO Box 016960 (D-110), Miami, FL 33101. E-mail: aboulton{at}med.miami.edu
Diabetic foot ulceration is a serious and expensive complication with considerable morbidity that affects up to 15% of diabetic patients during their lifetime; moreover, ∼80% of amputations are preceded by foot ulcers (1). Despite these facts, Mason et al. (2) concluded in their systematic review of treatments for foot lesions that the evidence base for treatments is poor. Furthermore, they criticized the majority of published trials of potentially promising treatments for neuropathic ulcers as being small, inadequately powered, and failing to use standardized methods and outcomes.
It is therefore refreshing to read the work of Kalani et al. (3) in this issue of Diabetes Care. In a well-designed controlled trial, patients with neuroischemic ulcers were randomized to receive daily subcutaneous low-molecular weight heparin (LMWH) or placebo. Those randomized to LMWH had significantly better outcomes with respect to healing rates and amputation. There are also potentially exciting new treatments for ischemic limbs in diabetes (4,5). Therapeutic …
