Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial

Sicco A Bus, Roelof Waaijman, Mark Arts, Mirjam de Haart, Tessa Busch-Westbroek, Jeff van Baal, Frans Nollet, Sicco A Bus, Roelof Waaijman, Mark Arts, Mirjam de Haart, Tessa Busch-Westbroek, Jeff van Baal, Frans Nollet

Abstract

Objective: Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence.

Research design and methods: We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken.

Results: On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045).

Conclusions: Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Mean in-shoe peak pressures over 18 months of follow-up for all previous ulcer locations with peak pressure at footwear delivery >200 kPa (red), all previous ulcer locations with peak pressure 200 kPa (green) for both the improved footwear (closed symbols) and the usual care (open symbols) groups. Changes in peak pressure at each follow-up in the improved footwear group are pressure changes after footwear modification. Error bars represent SEMs. IF, improved footwear; PUL, previous ulcer location; ROI, region of interest; UC, usual care.
Figure 3
Figure 3
Kaplan-Meier plots on cumulative survival of plantar foot ulcer recurrence over 18 months of follow-up with censored data for patients who died. A: Intention-to-treat (n = 171). B: Patients who adhered to wearing custom-made footwear (i.e., ≥80% of steps taken in custom-made footwear) (n = 79).

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Source: PubMed

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