medwireNews: Using smart insoles that alert patients to areas of high pressure can markedly reduce their risk for developing diabetic foot ulcers, show the findings of a randomized trial.
During 18 months of follow-up, the risk was reduced by 71% among patients receiving the intervention, Neil Reeves (Manchester Metropolitan University, UK) told delegates at the 54th EASD Annual Meeting in Berlin, Germany.
The insoles provide patients with “that feedback that they have lost naturally many years ago, due to diabetic peripheral neuropathy,” he said.
“In that respect, we would suggest that patients have really been empowered here, to take control of their foot health in a way that they haven’t been able to since the onset of significant diabetic peripheral neuropathy.”
However, the overall incidence of ulcers was relatively low even among patients in the control group, which Reeves speculated was because of the implementation of UK guidelines and all trial participants receiving monthly check-ups.
There were four new ulcers in four of the 32 patients receiving the intervention, which consisted of an insole with eight discrete pressure-sensing areas, linked to a “pod” that attaches to the top of the shoe and feeds information to a smart-watch (SurroSense Rx, Orpyx Medical Technologies, Calgary, Alberta, Canada).
All trial participants had no active ulcers at baseline. When the insole system detected an area of high pressure, it alerted the patient to its presence and location. When this happened, patients were instructed to walk around for 2 minutes, to actively take weight off the affected foot, and, if the pressure persisted, to remove their shoe and check for foreign bodies.
The 26 patients in the control group also wore the device, but they received no smart-watch feedback. There were 10 ulcers in six of the patients in this group.
Overall, patients in both groups wore the insoles for 6–7 hours per day, but there was a wide range of use among participants.
Among 40 patients who wore the insole for more than 4.5 hours per day, being in the active intervention group resulted in an 86% reduction in the risk for ulcers (two ulcers vs 10 in the control group).
In this subgroup, there was also a borderline significantly longer time to ulcer development, with the difference between the groups appearing from around 6 months.
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