Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study
Summary: Background: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients. Methods:...
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Elsevier
2019-10-01
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Series: | The Lancet: Digital Health |
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English |
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author |
Caroline A Abbott, PhD Katie E Chatwin, MSc Philip Foden, MSc Ahmad N Hasan, PhD Chandbi Sange, PhD Satyan M Rajbhandari, ProfMD Prabhav N Reddy, PhD Loretta Vileikyte, MD Frank L Bowling, DSc Andrew J M Boulton, ProfMD Neil D Reeves, ProfPhD |
spellingShingle |
Caroline A Abbott, PhD Katie E Chatwin, MSc Philip Foden, MSc Ahmad N Hasan, PhD Chandbi Sange, PhD Satyan M Rajbhandari, ProfMD Prabhav N Reddy, PhD Loretta Vileikyte, MD Frank L Bowling, DSc Andrew J M Boulton, ProfMD Neil D Reeves, ProfPhD Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study The Lancet: Digital Health |
author_facet |
Caroline A Abbott, PhD Katie E Chatwin, MSc Philip Foden, MSc Ahmad N Hasan, PhD Chandbi Sange, PhD Satyan M Rajbhandari, ProfMD Prabhav N Reddy, PhD Loretta Vileikyte, MD Frank L Bowling, DSc Andrew J M Boulton, ProfMD Neil D Reeves, ProfPhD |
author_sort |
Caroline A Abbott, PhD |
title |
Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
title_short |
Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
title_full |
Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
title_fullStr |
Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
title_full_unstemmed |
Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
title_sort |
innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study |
publisher |
Elsevier |
series |
The Lancet: Digital Health |
issn |
2589-7500 |
publishDate |
2019-10-01 |
description |
Summary: Background: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients. Methods: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete. Findings: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09–0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03–0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0–8·3) than non-re-ulcerating patients (2·0, 0·0–4·8; p=0·040). Interpretation: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence. Funding: Diabetes UK and Orpyx Medical Technologies. |
url |
http://www.sciencedirect.com/science/article/pii/S2589750019301281 |
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doaj-b06047f2a1f94d6aa91770e68781ed092020-11-25T01:18:05ZengElsevierThe Lancet: Digital Health2589-75002019-10-0116e308e318Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept studyCaroline A Abbott, PhD0Katie E Chatwin, MSc1Philip Foden, MSc2Ahmad N Hasan, PhD3Chandbi Sange, PhD4Satyan M Rajbhandari, ProfMD5Prabhav N Reddy, PhD6Loretta Vileikyte, MD7Frank L Bowling, DSc8Andrew J M Boulton, ProfMD9Neil D Reeves, ProfPhD10Research Centre for Musculoskeletal Science & Sports Medicine, Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK; Correspondence to: Dr Caroline A Abbott, Research Centre for Musculoskeletal Science & Sports Medicine, Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester M1 5GD, UKResearch Centre for Musculoskeletal Science & Sports Medicine, Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UKMedical Statistics Department, University Hospital of South Manchester NHS Foundation Trust, Manchester, UKResearch Centre for Musculoskeletal Science & Sports Medicine, Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK; Institute of Medical Science and Technology, University Kuala Lumpur, Kuala Lumpur, MalaysiaDiabetes Centre, Lancashire Teaching Hospitals NHS Foundation Trust, Lancashire, UKDiabetes Centre, Lancashire Teaching Hospitals NHS Foundation Trust, Lancashire, UKDepartment of Medical Physics and Biomedical Engineering, University College London, London, UKDepartment of Medicine, Manchester Royal Infirmary, Manchester, UK; Diabetes Research Institute, University of Miami, Miami, FL, USADivision of Diabetes, Endocrinology & Gastroenterology University of Manchester, Manchester, UKDepartment of Medicine, Manchester Royal Infirmary, Manchester, UK; Diabetes Research Institute, University of Miami, Miami, FL, USAResearch Centre for Musculoskeletal Science & Sports Medicine, Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UKSummary: Background: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients. Methods: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete. Findings: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09–0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03–0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0–8·3) than non-re-ulcerating patients (2·0, 0·0–4·8; p=0·040). Interpretation: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence. Funding: Diabetes UK and Orpyx Medical Technologies.http://www.sciencedirect.com/science/article/pii/S2589750019301281 |