Abstract
This study compared the outcome of an innovative in-shoe pressure and temperature measuring device as an adjunct to standard clinical care for diabetic foot versus standard clinical care alone. It included 88 participants with Type 2 diabetes mellitus with a history of one or more plantar foot ulceration who were already using prescription orthoses. These were randomly divided into the control group (n = 44, standard care only) and the experimental group (n = 44, standard care plus the innovative device). Both groups were monitored for re-ulceration for one year. Overall, the control group exhibited a higher number of re-ulcerations (n = 14) with 2 amputations in comparison with the experimental group (only 2 ulcerations and no amputations) at the end of the study. In conclusion, this innovative in-shoe pressure and temperature measuring device appears to reduce re-ulcerations by offering objective data for clinical decision making in the management of the diabetic high-risk foot.
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