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Infrared thermography and ulcer prevention in the high‐risk diabetic foot: data from a single‐blind multicentre controlled clinical trial

Petrova, N. L.; Donaldson, N. K.; Tang, W.; MacDonald, A.; Allen, J.; Lomas, C.; Leech, N.; Ainarkar, S.; Bevans, J.; Plassmann, P.; Kluwe, B.; Ring, F.; Whittam, A.; Rogers, L.; McMillan, J.; Simpson, R.; Donaldson, A. N. A.; Machin, G.; Edmonds, M. E. (2020) Infrared thermography and ulcer prevention in the high‐risk diabetic foot: data from a single‐blind multicentre controlled clinical trial. Diabetic Medicine, 37 (1). pp. 95-104. ISSN 0742-3071

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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.

Item Type: Article
Keywords: diabetes, diabetic foot ulceration, prevention, thermal imaging
Subjects: Engineering Measurements > Thermal
Divisions: Engineering
Identification number/DOI: 10.1111/dme.14152
Last Modified: 22 May 2020 09:35
URI: http://eprintspublications.npl.co.uk/id/eprint/8670

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