Infrared thermography and ulcer prevention in the high‐risk diabetic foot: data from a single‐blind multicentre controlled clinical trial. Issue 1 (13th November 2019)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Diabetic medicine. Volume 37:Issue 1(2020)
• Page Start: 95
• Page End: 104
• Publication Date: 2019-11-13
• Subjects: Diabetes -- Periodicals; 616.462
• DOI: 10.1111/dme.14152
• Languages: English
• ISSNs: 0742-3071

Abstract

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. What's new?: Areas of the foot with raised skin temperatures may be an indication of pre‐ulcerative inflammation in people with diabetes. We evaluated the utility of a novel thermal imaging device (the Diabetic Foot Ulcer Prevention System) in reducing foot ulcer recurrence in people with diabetes and history of ≥ 1 ulcer. Participants were randomized to intervention (active thermography + standard foot care) or control (blinded thermography + standard foot care) and assessed monthly until they developed a foot ulcer or for 12 months. Monthly intervention with thermography did not show a significant reduction in ulcer recurrence rate or increased ulcer‐free survival in this cohort at risk of foot ulcers.