A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting : application to feet at risk of diabetic plantar ulceration

Parker, DJ; Nuttall, GH; Bray, N; Hugill, T; Martinez Santos, A; Edwards, RT; Nester, CJ

Abstract

Background: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic
provision is a core strategy for the management of the people with diabetes and a moderate
to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic
device is to use manual casting of foot shape and physical moulding of orthoses materials.
Parts of this process can be undertaken using digital tools rather than manual processes with
potential advantages. The aim of this trial was to provide the first comparison of a traditional
orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar
pressure, health status, and health service time and cost data to compare the two supply
chains.

Methods: 57 participants with diabetes were randomly allocated to each supply chain. Plantar
pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at sixmonths.
The costs for orthoses and clinical services accessed by participants were assessed
over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at
the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes
were: reduction in plantar pressure at foot regions identified as at risk (>200kPa), costconsequence
analysis (supply chain, clinician time, service use) and health status.

Results: At point of supply pressure reduction for the digital supply chain was non-inferior to
a predefined margin and superior (p<0.1) to the traditional supply chain, but both supply chains
were inferior to the margin after six months. Custom-made orthoses significantly reduced
pressure for at risk regions compared to a flat control (traditional -13.85%, digital -20.52%).
The digital supply chain was more expensive (+£13.17) and required more clinician time
(+35minutes). There were no significant differences in health status or service use between
supply chains.

Conclusions: Custom made foot orthoses reduce pressure as expected. Given some
assumptions about the cost models we used, the supply chain process adopted to produce
the orthoses seems to have marginal impact on overall costs and health status.

Trial Registration: retrospectively registered on ISRCTN registry (ISRCTN10978940,
04/11/2015).
Key Words: Foot Orthotic, Biomechanics, Diabetes, Plantar Pressure, Cost, Health
Economics, Supply Chain

• Journal Article Type: Article
• Acceptance Date: Dec 10, 2018
• Online Publication Date: Jan 8, 2019
• Publication Date: Jan 8, 2019
• Deposit Date: Dec 10, 2018
• Publicly Available Date: Jan 10, 2019
• Journal: Journal of Foot and Ankle Research
• Electronic ISSN: 1757-1146
• Publisher: Springer Verlag
• Volume: 12
• Issue: 2
• DOI: https://doi.org/10.1186/s13047-018-0311-0
• Publisher URL: https://doi.org/10.1186/s13047-018-0311-0
• Related Public URLs: https://jfootankleres.biomedcentral.com/