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

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Presentation transcript:

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study Caroline A Abbott, PhD, Katie E Chatwin, MSc, Philip Foden, MSc, Ahmad N Hasan, PhD, Chandbi Sange, PhD, Prof Satyan M Rajbhandari, MD, Prabhav N Reddy, PhD, Loretta Vileikyte, MD, Frank L Bowling, DSc, Prof Andrew J M Boulton, MD, Prof Neil D Reeves, PhD The Lancet Digital Health Volume 1, Issue 6, Pages e308-e318 (October 2019) DOI: 10.1016/S2589-7500(19)30128-1 Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Terms and Conditions

Figure 1 SurroSense Rx intelligent insole system (Orpyx Medical Technologies, Calgary, AB, Canada) (A) Intelligent insole system, comprising 0·6 mm flexible, pressure-sensing inserts (placed underneath the patient's own orthotics or insoles) and a connecting smartwatch. (B) Sites of the pressure sensors: first metatarsal head [one sensor], lateral metatarsal heads [two sensors], hallux [one sensor], lateral toes [one sensor], lateral foot [two sensors], and heel [one sensor]. (C–E) Smartwatch screen displaying a user-friendly, visual foot map, highlighting areas of high pressure. The device integrates pressure data over time and uses this to generate alerts for the user. The user must respond to the alert by offloading the area of high pressure on their foot; the watch will continue to provide alerts until the pressure has been offloaded. The Lancet Digital Health 2019 1, e308-e318DOI: (10.1016/S2589-7500(19)30128-1) Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Terms and Conditions

Figure 2 CONSORT study flow diagram The Lancet Digital Health 2019 1, e308-e318DOI: (10.1016/S2589-7500(19)30128-1) Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Terms and Conditions

Figure 3 Kaplan-Meier plots on cumulative survival of plantar foot ulcer recurrence (A) Intention-to-treat population (n=58). (B) Patients who were highly compliant in wearing their intelligent insole system (n=40). The Lancet Digital Health 2019 1, e308-e318DOI: (10.1016/S2589-7500(19)30128-1) Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Terms and Conditions