Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study.

摘要: © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard care methods, remains a challenge. We hypothesised that innovative intelligent insole system would be effective reducing such patients. Methods: In this prospective, randomised, proof-of-concept study, patients with diabetes, and peripheral neuropathy recent history plantar ulceration were recruited from two multidisciplinary outpatient clinics UK, randomly assigned to either intervention or control. All received system, which measured pressure continuously during daily life. group audiovisual alerts via smartwatch linked offloading instructions when aberrant pressures detected; control did not receive any alerts. primary outcome was occurrence within 18 months. trial registered ISRCTN, ISRCTN05585501, closed accrual complete. Findings: Between March 18, 2014, Dec 20, 2016, 90 consented 58 completed study. At follow-up, ten ulcers 8638 person-days recorded four 11 835 group: 71% reduction incidence compared (incidence rate ratio 0·29, 95% CI, 0·09–0·93; p=0·037). number who ulcerated similar between groups (six 26 [control group] vs 32 [intervention group]; p=0·29); however, individual sites more often (ten 416) than (four 512; p=0·047). exploratory analysis good compliers (n=40), reduced 86% versus 0·14, CI 0·03–0·63; p=0·011). analysis, callus severity (change baseline 6 months) greater re-ulcerating (6·5, IQR 4·0–8·3) non-re-ulcerating (2·0, 0·0–4·8; p=0·040). Interpretation: To our knowledge, study first show continuous monitoring dynamic guidance, provided can lead site recurrence. Funding: Diabetes UK Orpyx Medical Technologies.