N L Petrova1,2, N K Donaldson1, W Tang1, A MacDonald3, J Allen3, C Lomas4, N Leech4, S Ainarkar5, J Bevans5, P Plassmann6, B Kluwe7, F Ring7, A Whittam8, L Rogers8, J McMillan8, R Simpson8, A N A Donaldson1, G Machin8, M E Edmonds1,2. 1. Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, London, UK. 2. Division of Diabetes and Nutritional Sciences, King's College London, London, UK. 3. Microvascular Diagnostics, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK. 4. Podiatry Department, Diabetes Centre, Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle-upon-Tyne, UK. 5. Community Podiatry Department, Pennine Acute Hospitals Trust, Manchester, UK. 6. Photometrix Imaging Ltd, Pontypridd, UK. 7. Department of Computing, University of South Wales, Pontypridd, UK. 8. Temperature and Humidity, National Physical Laboratory, London, UK.
Abstract
AIM: To assess the usefulness of monthly thermography and standard foot care to reduce diabetic foot ulcer recurrence. METHODS:People with diabetes (n = 110), neuropathy and history of ≥ 1 foot ulcer participated in a single-blind multicentre clinical trial. Feet were imaged with a novel thermal imaging device (Diabetic Foot Ulcer Prevention System). Participants were randomized to intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care) and were followed up monthly until ulcer recurrence or for 12 months. Foot thermograms of participants from the intervention group were assessed for hot spots (areas with temperature ≥ 2.2°C higher than the corresponding contralateral site) and acted upon as per local standards. RESULTS: After 12 months, 62% of participants were ulcer-free in the intervention group and 56% in the control group. The odds ratios of ulcer recurrence (intervention vs control) were 0.82 (95% CI 0.38, 1.8; P = 0.62) and 0.55 (95% CI 0.21, 1.4; P = 0.22) in univariate and multivariate logistic regression analyses, respectively. The hazard ratios for the time to ulcer recurrence (intervention vs control) were 0.84 (95% CI 0.45, 1.6; P = 0.58) and 0.67 (95% CI 0.34, 1.3; P = 0.24) in univariate and multivariate Cox regression analyses, respectively. CONCLUSIONS: Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers. This trial has, however, informed the design of a refined study with longer follow-up and group stratification, further aiming to assess the efficacy of thermography to reduce ulcer recurrence.
RCT Entities:
AIM: To assess the usefulness of monthly thermography and standard foot care to reduce diabetic foot ulcer recurrence. METHODS:People with diabetes (n = 110), neuropathy and history of ≥ 1 foot ulcer participated in a single-blind multicentre clinical trial. Feet were imaged with a novel thermal imaging device (Diabetic Foot Ulcer Prevention System). Participants were randomized to intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care) and were followed up monthly until ulcer recurrence or for 12 months. Foot thermograms of participants from the intervention group were assessed for hot spots (areas with temperature ≥ 2.2°C higher than the corresponding contralateral site) and acted upon as per local standards. RESULTS: After 12 months, 62% of participants were ulcer-free in the intervention group and 56% in the control group. The odds ratios of ulcer recurrence (intervention vs control) were 0.82 (95% CI 0.38, 1.8; P = 0.62) and 0.55 (95% CI 0.21, 1.4; P = 0.22) in univariate and multivariate logistic regression analyses, respectively. The hazard ratios for the time to ulcer recurrence (intervention vs control) were 0.84 (95% CI 0.45, 1.6; P = 0.58) and 0.67 (95% CI 0.34, 1.3; P = 0.24) in univariate and multivariate Cox regression analyses, respectively. CONCLUSIONS: Monthly intervention with thermal imaging did not result in a significant reduction in ulcer recurrence rate or increased ulcer-free survival in this cohort at high risk of foot ulcers. This trial has, however, informed the design of a refined study with longer follow-up and group stratification, further aiming to assess the efficacy of thermography to reduce ulcer recurrence.
Authors: Jonathan Golledge; Malindu Fernando; Peter Lazzarini; Bijan Najafi; David G Armstrong Journal: Sensors (Basel) Date: 2020-08-13 Impact factor: 3.576
Authors: Jonathan Golledge; Malindu E Fernando; Chanika Alahakoon; Peter A Lazzarini; Wouter B Aan de Stegge; Jaap J van Netten; Sicco A Bus Journal: Diabetes Metab Res Rev Date: 2022-06-08 Impact factor: 8.128
Authors: Christopher Beach; Glen Cooper; Andrew Weightman; Emma F Hodson-Tole; Neil D Reeves; Alexander J Casson Journal: Sensors (Basel) Date: 2021-03-02 Impact factor: 3.576