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The online version of this article (https://doi.org/10.1186/s13047-018-0311-0) contains supplementary material, which is available to authorized users.
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.
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.
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 6 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 (+ 35 min). There were no significant differences in health status or service use between supply chains.
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.
Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).
Owings TM, Apelqvist J, Stenström A, Becker M, Bus SA, Kalpen A, et al. Plantar pressures in diabetic patients with foot ulcers which have remained healed. Diabet Med. 2009;26:1141–6. https://doi.org/10.1111/j.1464-5491.2009.02835.x. CrossRefPubMed
Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlaváček P, et al. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev. 2008;24:S162–80. https://doi.org/10.1002/dmrr.850. CrossRefPubMed
Telfer S, Gibson KS, Hennessy K, Steultjens MP, Woodburn J. Computer-aided Design of Customized Foot Orthoses: reproducibility and effect of method used to obtain foot shape. Arch Phys Med Rehabil. 2012;93:863–70. https://doi.org/10.1016/j.apmr.2011.12.019. CrossRefPubMed
Telfer S, Woodburn J, Collier A, Cavanagh PR. Virtually optimized insoles for offloading the diabetic foot: a randomized crossover study. J Biomech. 2017;60:157–61. https://doi.org/10.1016/j.jbiomech.2017.06.028. CrossRefPubMed
Burns J, Wegener C, Begg L, Vicaretti M, Fletcher J. Randomized trial of custom orthoses and footwear on foot pain and plantar pressure in diabetic peripheral arterial disease. Diabet Med. 2009;26:893–9. https://doi.org/10.1111/j.1464-5491.2009.02799.x. CrossRefPubMed
Paton JS, Stenhouse EA, Bruce G, Zahra D, Jones RB. A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial. J Foot Ankle Res. 2012;5:31. https://doi.org/10.1186/1757-1146-5-31. CrossRefPubMedPubMedCentral
Ashry HR, Lavery LA, Murdoch DP, Frolich M, Lavery DC. Effectiveness of diabetic insoles to reduce foot pressures. J Foot Ankle Surg. 1997;36:268–71. https://doi.org/10.1016/S1067-2516(97)80071-3. CrossRefPubMed
San Tsung BY, Zhang M, Mak AFT, Wong MWN. Effectiveness of insoles on plantar pressure redistribution. J Rehabil Res Dev. 2004;41:767–74. CrossRef
Hellstrand Tang U, Zügner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers – a two-year, randomized trial. J Clin Transl Endocrinol. 2014;1:121–32. https://doi.org/10.1016/J.JCTE.2014.06.002. CrossRefPubMedPubMedCentral
FDA, CDER, CBER. Non-inferiority clinical trials to establish effectiveness guidance for industry 2016. https://www.fda.gov/downloads/Drugs/Guidances/UCM202140.pdf. Accessed 3 July 2018.
Bus SA, Ulbrecht JS, Cavanagh PR. Pressure relief and load redistribution by custom-made insoles in diabetic patients with neuropathy and foot deformity. Clin Biomech. 2004;19:629–38. https://doi.org/10.1016/j.clinbiomech.2004.02.010. CrossRef
Martinez-Santos A. An investigation into the effect of customised insoles on plantar pressures in people with diabetes. Salford, UK: The University of Salford; 2016.
Sealed Envelope | Power calculator for continuous outcome non-inferiority trial 2012. https://www.sealedenvelope.com/power/continuous-noninferior/. Accessed 22 Nov 2018.
Gerard E. Dallal. Randomization.com 2008. http://www.randomization.com.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208. CrossRef
Curtis L, Burns A. Unit costs of health and social care 2015. 2015. https://www.pssru.ac.uk/project-pages/unit-costs/unit-costs-2015/?file=full. Accessed 6 May 2018.
Department of Health. National Health Schedule of Reference Costs 2014 to 2015. 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/477919/2014-15_Reference_costs_publication.pdf. Accessed 6 May 2018.
van Hout B, Janssen MF, Feng Y-S, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15:708–15. https://doi.org/10.1016/j.jval.2012.02.008. CrossRefPubMed
Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997;6:327–40. https://doi.org/10.1002/(SICI)1099-1050(199707)6:4<327::AID-HEC282>3.0.CO;2-W. CrossRefPubMed
Perspective - York Health Economics Consortium 2016. https://www.yhec.co.uk/glossary/perspective/. Accessed 22 Nov 2018.
Dawson J, Fitzpatrick R, Frost S, Gundle R, McLardy-Smith P, Murray D. Evidence for the validity of a patient-based instrument for assessment of outcome after revision hip replacement. J Bone Joint Surg Br. 2001;83:1125–9. CrossRef
Jansson K-Å, Granath F. Health-related quality of life (EQ-5D) before and after orthopedic surgery. Acta Orthop. 2011;82:82–9. https://doi.org/10.3109/17453674.2010.548026. CrossRefPubMedPubMedCentral
Price C, Parker D, Nester C. Validity and repeatability of three in-shoe pressure measurement systems. Gait Posture. 2016;46. https://doi.org/10.1016/j.gaitpost.2016.01.026.
Cavanagh PR, Ulbrecht JS, Caputo GM. New developments in the biomechanics of the diabetic foot. Diabetes Metab Res Rev. n.d.;16:S6–10. https://doi.org/10.1002/1520-7560(200009/10)16:1+<::AID-DMRR130>3.0.CO;2-Z.
- 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
D. J. Parker
G. H. Nuttall
R. T. Edwards
- BioMed Central