Advertisement

Evaluation of novel plantar pressure-based 3-dimensional printed accommodative insoles - A feasibility study

  • Author Footnotes
    1 BC Muir and JS Li contributed to this work as first authors.
    Brittney C. Muir
    Correspondence
    Corresponding author at: Center for Limb Loss and MoBility (CLiMB), VA Puget Sound Health Care System, 1660 South Columbian Way, MS 151, Seattle, WA 98108, USA.
    Footnotes
    1 BC Muir and JS Li contributed to this work as first authors.
    Affiliations
    Department of Mechanical Engineering, University of Washington, Seattle, WA, USA

    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • Author Footnotes
    1 BC Muir and JS Li contributed to this work as first authors.
    Jing-Sheng Li
    Footnotes
    1 BC Muir and JS Li contributed to this work as first authors.
    Affiliations
    Department of Mechanical Engineering, University of Washington, Seattle, WA, USA

    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • Yuri F. Hudak
    Affiliations
    Department of Mechanical Engineering, University of Washington, Seattle, WA, USA

    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • G. Eli Kaufman
    Affiliations
    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • Scott Cullum
    Affiliations
    Department of Mechanical Engineering, University of Washington, Seattle, WA, USA

    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • Patrick M. Aubin
    Affiliations
    Department of Mechanical Engineering, University of Washington, Seattle, WA, USA

    VA RR&D Center for Limb Loss and MoBility (CLiMB), Seattle, WA, USA
    Search for articles by this author
  • Author Footnotes
    1 BC Muir and JS Li contributed to this work as first authors.

      Highlights

      • Two types of 3D-printed insoles with personalized metamaterials were designed.
      • Both 3D-printed insoles reduced plantar pressure in offloading regions (>200 kPa).
      • Both 3D-printed insoles did not induce any adverse events during testing.
      • 3D-printed insoles show potential to improve the current standard of care.

      Abstract

      Background

      Custom insoles are commonly prescribed to patients with diabetes to redistribute plantar pressure and decrease the risk of ulceration. Advances in 3D printing have enabled the creation of 3D-printed personalized metamaterials whose properties are derived not only from the base material but also the lattice microstructures within the metamaterial. Insoles manufactured using personalized metamaterials have both patient-specific geometry and stiffnesses. However, the safety and biomechanical effect of the novel insoles have not yet been tested clinically.

      Methods

      Individuals without ulcer, neuropathy, or deformity were recruited for this study. In-shoe walking plantar pressure at baseline visit was taken and sensels with pressure over 200 kPa was used to define offloading region(s). Three pairs of custom insoles (two 3D printed insoles with personalized metamaterials (Hybrid and Full) designed based on foot shape and plantar pressure mapping and one standard-of-care diabetic insole as a comparator). In-shoe plantar pressure measurements during walking were recorded in a standardized research shoe and the three insoles and compared across all four conditions.

      Findings

      Twelve individuals were included in the final analysis. No adverse events occurred during testing. Maximum peak plantar pressure and the pressure time integral were reduced in the offloading regions in the Hybrid and Full but not in the standard-of-care compared to the research shoe.

      Interpretation

      This feasibility study confirms our ability to manufacture the 3D printed personalized metamaterials insoles and demonstrates their ability to reduce plantar pressure. We have demonstrated the ability to modify the 3D printed design to offload certain parts of the foot using plantar pressure data and a patient-specific metamaterials in the 3D printed insole design. The advance in 3D printed technology has shown its potential to improve current care.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Clinical Biomechanics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Ahmed S.
        • Barwick A.
        • Butterworth P.
        • Nancarrow S.
        Footwear and insole design features that reduce neuropathic plantar forefoot ulcer risk in people with diabetes: a systematic literature review.
        J. Foot Ankle Res. logo J. Foot Ankle Res. 2020; 13https://doi.org/10.1186/s13047-020-00400-4
        • Apelqvist J.
        • Larsson J.
        What is the most effective way to reduce incidence of amputation in the diabetic foot?.
        Diabetes Metab. Res. Rev. 2000; 16https://doi.org/10.1002/1520-7560(200009/10)16:1+<::AID-DMRR139>3.0.CO;2-8
        • Apelqvist J.
        • Larsson J.
        • Agardh C.-D.
        Long-term prognosis for diabetic patients with foot ulcers.
        J. Intern. Med. 1993; 233: 485-491https://doi.org/10.1111/J.1365-2796.1993.TB01003.X
        • Arts M.L.J.
        • Bus S.A.
        Twelve steps per foot are recommended for valid and reliable in-shoe plantar pressure data in neuropathic diabetic patients wearing custom made footwear.
        Clin. Biomech. 2011; 26: 880-884https://doi.org/10.1016/j.clinbiomech.2011.05.001
        • Arts M.L.J.
        • de Haart M.
        • Waaijman R.
        • Dahmen R.
        • Berendsen H.
        • Nollet F.
        • Bus S.A.
        Data-driven directions for effective footwear provision for the high-risk diabetic foot.
        Diabet. Med. 2015; 32: 790-797https://doi.org/10.1111/DME.12741
        • Bus S.A.
        • Haspels R.
        • Busch-Westbroek T.E.
        Evaluation and Optimization of Therapeutic Footwear for Neuropathic Diabetic Foot Patients Using In-Shoe Plantar Pressure Analysis.
        2011https://doi.org/10.2337/dc10-2206
        • Bus Si A.
        • Waaijman R.
        • Arts M.
        • de Haart M.
        • Busch-Westbroek T.
        • van Baal J.
        • Nollet F.
        Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial.
        Diabetes Care. 2013; 36: 4109-4116https://doi.org/10.2337/dc13-0996
        • Bus S.A.
        • van Deursen R.W.
        • Armstrong D.G.
        • Lewis J.E.A.
        • Caravaggi C.F.
        • Cavanagh P.R.
        Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review.
        Diabetes Metab. Res. Rev. 2016; 32: 99-118https://doi.org/10.1002/dmrr.2702
        • Bus S.A.
        • Armstrong D.G.
        • Gooday C.
        • Jarl G.
        • Caravaggi C.
        • Viswanathan V.
        • Lazzarini P.A.
        Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update).
        Diabetes Metab. Res. Rev. 2020; 36: 1https://doi.org/10.1002/DMRR.3274
        • Bus S.A.
        • Lavery L.A.
        • Monteiro-Soares M.
        • Rasmussen A.
        • Raspovic A.
        • Sacco I.C.N.
        • van Netten J.J.
        Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2019 update).
        Diabetes Metab. Res. Rev. 2020; 36: 1https://doi.org/10.1002/DMRR.3269
        • Centers for Disease Control and Prevention
        National Diabetes Statistics Report, 2017. GA.
        2017
        • Chevalier T.L.
        • Hodgins H.
        • Chockalingam N.
        Plantar pressure measurements using an in-shoe system and a pressure platform: a comparison.
        Gait Posture. 2010; 31: 397-399https://doi.org/10.1016/J.GAITPOST.2009.11.016
        • 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: 121-132https://doi.org/10.1016/J.JCTE.2014.06.002
        • Hudak Y.F.
        • Li J.S.
        • Cullum S.
        • Strzelecki B.M.
        • Richburg C.
        • Kaufman G.E.
        • Abrahamson D.
        • Heckman J.T.
        • Ripley B.
        • Telfer S.
        • Ledoux W.R.
        • Muir B.C.
        • Aubin P.M.
        A novel workflow to fabricate a patient-specific 3D printed accommodative foot orthosis with personalized latticed metamaterial.
        Med. Eng. Phys. 2022; 104103802https://doi.org/10.1016/J.MEDENGPHY.2022.103802
        • Hurkmans H.L.P.
        • Bussmann J.B.J.
        • Benda E.
        • Verhaar J.A.N.
        • Stam H.J.
        Accuracy and repeatability of the Pedar Mobile system in long-term vertical force measurements.
        Gait Posture. 2006; 23: 118-125https://doi.org/10.1016/J.GAITPOST.2005.05.008
        • Julious S.A.
        Sample size of 12 per group rule of thumb for a pilot study.
        Pharm. Stat. 2005; 4: 287-291https://doi.org/10.1002/PST.185
        • Lavery L.A.
        • LaFontaine J.
        • Higgins K.R.
        • Lanctot D.R.
        • Constantinides G.
        Shear-reducing insoles to prevent foot ulceration in high-risk diabetic patients.
        Adv. Skin Wound Care. 2012; 25: 519-524https://doi.org/10.1097/01.ASW.0000422625.17407.93
        • Lewis J.
        • Lipp A.
        Pressure-relieving interventions for treating diabetic foot ulcers.
        Cochrane Database Syst. Rev. 2013; https://doi.org/10.1002/14651858.CD002302.pub2
        • Martinez-Santos A.
        • Preece S.
        • Nester C.J.
        Evaluation of orthotic insoles for people with diabetes who are at-risk of first ulceration.
        J. Foot Ankle Res. 2019; 12: 1-9https://doi.org/10.1186/S13047-019-0344-Z/FIGURES/4
        • Melai T.
        • IJzerman T.H.
        • Schaper N.C.
        • de Lange T.L.H.
        • Willems P.J.B.
        • Meijer K.
        • Lieverse A.G.
        • Savelberg H.H.C.M.
        Calculation of plantar pressure time integral, an alternative approach.
        Gait Posture. 2011; 34: 379-383https://doi.org/10.1016/J.GAITPOST.2011.06.005
        • Mueller M.J.
        • Lott D.J.
        • Hastings M.K.
        • Commeam P.K.
        • Smith K.E.
        • Pilgram T.K.
        Efficacy and mechanism of orthotic devices to unload metatarsal heads in people with diabetes and a history of plantar ulcers.
        Phys. Ther. 2006; 86: 833-842https://doi.org/10.1093/PTJ/86.6.833
        • Owings T.M.
        • Woerner J.L.
        • Frampton J.D.
        • Cavanagh P.R.
        • Botek G.
        Custom Therapeutic Insoles Based on Both Foot Shape and Plantar Pressure Measurement Provide Enhanced Pressure Relief.
        2008https://doi.org/10.2337/dc07
        • Owings T.M.
        • Apelqvist J.
        • Stenström A.
        • Becker M.
        • Bus S.A.
        • Kalpen A.
        • Ulbrecht J.S.
        • Cavanagh P.R.
        Plantar pressures in diabetic patients with foot ulcers which have remained healed.
        Diabet. Med. 2009; 26: 1141-1146https://doi.org/10.1111/J.1464-5491.2009.02835.X
        • Paton J.S.
        • Stenhouse E.A.
        • Bruce G.
        • Zahra D.
        • Jones R.B.
        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: 1-11https://doi.org/10.1186/1757-1146-5-31/TABLES/4
        • Pecoraro R.E.
        • Reiber G.E.
        • Burgess E.M.
        Pathways to diabetic limb amputation: basis for prevention.
        Diabetes Care. 1990; 13: 513-521https://doi.org/10.2337/diacare.13.5.513
        • Petre M.
        • Erdemir A.
        • Panoskaltsis V.P.
        • Spirka T.A.
        • Cavanagh P.R.
        Optimization of nonlinear hyperelastic coefficients for foot tissues using a magnetic resonance imaging deformation experiment.
        J. Biomech. Eng. 2013; 135https://doi.org/10.1115/1.4023695
        • Quesada P.M.
        • Rash G.S.
        • Jarboe N.
        Assessment of pedar and F-scan revisited.
        Clin. Biomech. (Bristol, Avon). 1997; 12: S15https://doi.org/10.1016/S0268-0033(97)88328-3
        • Sattari S.
        • Ashraf A.R.
        Comparison the effect of 3 point valgus stress knee support and lateral wedge insoles in medial compartment knee osteoarthritis.
        Iran. Red Crescent Med. J. 2011; 13: 624-628https://doi.org/10.5812/kowsar.20741804.2252
        • Schirr-Bonnans S.
        • Costa N.
        • Derumeaux-Burel H.
        • Bos J.
        • Lepage B.
        • Garnault V.
        • Martini J.
        • Hanaire H.
        • Turnin M.C.
        • Molinier L.
        Cost of diabetic eye, renal and foot complications: a methodological review.
        Eur. J. Health Econ. 2017; 18: 293-312https://doi.org/10.1007/S10198-016-0773-6
        • Sun H.
        • Saeedi P.
        • Karuranga S.
        • Pinkepank M.
        • Ogurtsova K.
        • Duncan B.B.
        • Stein C.
        • Basit A.
        • Chan J.C.N.
        • Mbanya J.C.
        • Pavkov M.E.
        • Ramachandaran A.
        • Wild S.H.
        • James S.
        • Herman W.H.
        • Zhang P.
        • Bommer C.
        • Kuo S.
        • Boyko E.J.
        • Magliano D.J.
        IDF diabetes atlas: global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045.
        Diabetes Res. Clin. Pract. 2021; 183 (109119–109119)https://doi.org/10.1016/J.DIABRES.2021.109119
        • Ulbrecht J.S.
        • Hurley T.
        • Mauger D.T.
        • Cavanagh P.R.
        Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.
        Diabetes Care. 2014; 37: 1982-1989https://doi.org/10.2337/dc13-2956
        • Viswanathan V.
        • Madhavan S.
        • Gnanasundaram S.
        • Gopalakrishna G.
        • Nath Das B.
        • Rajasekar S.
        • Ramachandran A.
        Effectiveness of different types of footwear insoles for the diabetic neuropathic foot: a follow-up study.
        Diabetes Care. 2004; 27: 474-477https://doi.org/10.2337/diacare.27.2.474
        • Waaijman R.
        • Arts M.L.J.
        • Haspels R.
        • Busch-Westbroek T.E.
        • Nollet F.
        • Bus S.A.
        Pressure-reduction and preservation in custom-made footwear of patients with diabetes and a history of plantar ulceration.
        Diabet. Med. 2012; 29: 1542-1549https://doi.org/10.1111/J.1464-5491.2012.03700.X