Abstract
This study determined the incidence, pivotal events, etiology, and levels of amputation in a prospectively followed cohort of 400 people with diabetes and a prior healed foot ulcer who participated in a randomized footwear trial. Participants were seen every 17 weeks for 2 years. Subjects with foot lesions were referred to their healthcare provider for treatment. In this cohort, 11 participants required lower limb amputation (rate 13.8 per 1000 person-years). Pivotal event analysis revealed that only one amputation was related to footwear, six amputations were due to non-footwear-related minor environmental trauma, two were due to progression of vascular disease (dry gangrene from critical ischemia), one was due to a self-care injury while cutting the toenails, and one was due to a decubitus ulcer. Previously proposed strategies to reduce the amputation rates in individuals with diabetes have focused heavily on footwear and education. However, even with this emphasis, amputation rates in the United States are still high. This study suggests that the prevention of minor environmental trauma, including household accidents, merits additional attention. We believe that further efforts to reduce amputation rates for individuals with diabetes will need to emphasize the prevention of minor trauma, especially in those already compromised with neuropathy and vascular disease.
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