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.

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

Fifty-seven 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 six-months. 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 (> 200 kPa), cost-consequence 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 (

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).

Déclaration de conflit d'intérêts

Ethical approval was provided by the University of Salford, School of Health Sciences ethics committee (HSCR15–89) and national health service committees (REC ref.: 15/YH/0392). Participants gave informed consent prior to data collection.Not applicable.CN is a Director and owns equity in a company (Salfordinsole healthcare Ltd) that manufacturers foot orthoses. The company was a partner in the project that funded this study but provided no direct funding. The company provided access to its insole designs. CN took no part in the design of orthoses, nor data collection and analysis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.