Evidence for orthotic treatment of the moderate / high risk or in-remission diabetic foot

Meta Analyses

Crawford, F., Nicolson, D.J., Amanna, A.E., Martin, A., Gupta, S., Leese, G.P., Heggie, R., Chappell, F.M. and McIntosh, H.H., 2020. Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data. Diabetologia, 63(1), p.49.
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Elraiyah, T., Prutsky, G., Domecq, J.P., Tsapas, A., Nabhan, M., Frykberg, R.G., Firwana, B., Hasan, R., Prokop, L.J. and Murad, M.H., 2016. A systematic review and meta-analysis of off-loading methods for diabetic foot ulcers. Journal of vascular surgery, 63(2), pp.59S-68S.
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Systematic Reviews

Chatwin, K.E., Abbott, C.A., Boulton, A.J., Bowling, F.L. and Reeves, N.D., 2019. The role of foot pressure measurement in the prediction and prevention of diabetic foot ulceration—A comprehensive review. Diabetes/Metabolism Research and Reviews, p.e3258.
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Collings, R., Freeman, J., Latour, J.M., Glasser, S. and Paton, J., 2017. Footwear and insole design features to prevent foot ulceration in people with diabetes: a systematic review protocol. JBI database of systematic reviews and implementation reports, 15(7), pp.1824-1834.
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Healy, A., Farmer, S., Pandyan, A. and Chockalingam, N., 2018. A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions. PloS one, 13(3), p.e0192094.
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Heuch, L. and Gomersall, J.S., 2016. Effectiveness of offloading methods in preventing primary diabetic foot ulcers in adults with diabetes: a systematic review. JBI database of systematic reviews and implementation reports, 14(7), pp.236-265.
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Paton, J., Bruce, G., Jones, R. and Stenhouse, E., 2011. Effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot: a systematic review. Journal of Diabetes and its Complications, 25(1), pp.52-62.
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Paton, J., Hatton, A.L., Rome, K. and Kent, B., 2016. Effects of foot and ankle devices on balance, gait and falls in adults with sensory perception loss: a systematic review. JBI database of systematic reviews and implementation reports, 14(12), p.127.
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Searle, A., Spink, M.J., Ho, A. and Chuter, V.H., 2017. Association between ankle equinus and plantar pressures in people with diabetes. A systematic review and meta-analysis. Clinical Biomechanics, 43, pp.8-14.
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Randomised Controlled Trials

Burns, J., Wegener, C., Begg, L., Vicaretti, M. and Fletcher, J., 2009. Randomized trial of custom orthoses and footwear on foot pain and plantar pressure in diabetic peripheral arterial disease. Diabetic medicine, 26(9), pp.893-899.
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Lavery, L.A., Higgins, K.R., La Fontaine, J., Zamorano, R.G., Constantinides, G.P. and Kim, P.J., 2015. Randomised clinical trial to compare total contact casts, healing sandals and a shear‐reducing removable boot to heal diabetic foot ulcers. International wound journal, 12(6), pp.710-715.
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Parker, D.J., Nuttall, G.H., Bray, N., Hugill, T., Martinez-Santos, A., Edwards, R.T. and Nester, C., 2019. 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. Journal of foot and ankle research, 12(1), p.2.
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Paton, J.S., Stenhouse, E.A., Bruce, G., Zahra, D. and Jones, R.B., 2012. A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial. Journal of foot and ankle research, 5(1), p.31.
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Reiber, G.E., Smith, D.G., Wallace, C., Sullivan, K., Hayes, S., Vath, C., Maciejewski, M.L., Yu, O., Heagerty, P.J. and LeMaster, J., 2002. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. Jama, 287(19), pp.2552-2558.
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Rizzo, L., Tedeschi, A., Fallani, E., Coppelli, A., Vallini, V., Iacopi, E. and Piaggesi, A., 2012. Custom-made orthesis and shoes in a structured follow-up program reduces the incidence of neuropathic ulcers in high-risk diabetic foot patients. The international journal of lower extremity wounds, 11(1), pp.59-64.
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Scire, V., Leporati, E., Teobaldi, I., Nobili, L.A., Rizzo, L. and Piaggesi, A., 2009. Effectiveness and safety of using Podikon digital silicone padding in the primary prevention of neuropathic lesions in the forefoot of diabetic patients. Journal of the American Podiatric Medical Association, 99(1), pp.28-34.
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Ulbrecht, J.S., Hurley, T., Mauger, D.T. and Cavanagh, P.R., 2014. Prevention of recurrent foot ulcers with plantar pressure–based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes care, p.DC_132956.
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For orthotic interventions where large volumes of high quality evidence exist, lower levels of evidence have not been included in the Orthotics Evidence Portal.

Meta Analyses

Crawford, F., Nicolson, D.J., Amanna, A.E., Martin, A., Gupta, S., Leese, G.P., Heggie, R., Chappell, F.M. and McIntosh, H.H., 2020. Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data. Diabetologia, 63(1), p.49.
Click here for Article

Elraiyah, T., Prutsky, G., Domecq, J.P., Tsapas, A., Nabhan, M., Frykberg, R.G., Firwana, B., Hasan, R., Prokop, L.J. and Murad, M.H., 2016. A systematic review and meta-analysis of off-loading methods for diabetic foot ulcers. Journal of vascular surgery, 63(2), pp.59S-68S.
Click here for Article

Systematic Reviews

Chatwin, K.E., Abbott, C.A., Boulton, A.J., Bowling, F.L. and Reeves, N.D., 2019. The role of foot pressure measurement in the prediction and prevention of diabetic foot ulceration—A comprehensive review. Diabetes/Metabolism Research and Reviews, p.e3258.
Click here for Article

Collings, R., Freeman, J., Latour, J.M., Glasser, S. and Paton, J., 2017. Footwear and insole design features to prevent foot ulceration in people with diabetes: a systematic review protocol. JBI database of systematic reviews and implementation reports, 15(7), pp.1824-1834.
Click here for Article

Healy, A., Farmer, S., Pandyan, A. and Chockalingam, N., 2018. A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions. PloS one, 13(3), p.e0192094.
Click here for Article

Healy, A., Naemi, R. and Chockalingam, N., 2014. The effectiveness of footwear and other removable off-loading devices in the treatment of diabetic foot ulcers: a systematic review. Current diabetes reviews, 10(4), pp.215-230.
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Heuch, L. and Gomersall, J.S., 2016. Effectiveness of offloading methods in preventing primary diabetic foot ulcers in adults with diabetes: a systematic review. JBI database of systematic reviews and implementation reports, 14(7), pp.236-265.
Click here for Article

Pérez-Panero, A.J., Ruiz-Muñoz, M., Cuesta-Vargas, A.I. and Gónzalez-Sánchez, M., 2019. Prevention, assessment, diagnosis and management of diabetic foot based on clinical practice guidelines: A systematic review. Medicine, 98(35).
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van Netten, J.J., Sacco, I.C., Lavery, L.A., Monteiro‐Soares, M., Rasmussen, A., Raspovic, A. and Bus, S.A., 2020. Treatment of modifiable risk factors for foot ulceration in persons with diabetes: a systematic review. Diabetes/Metabolism Research and Reviews, p.e3271.
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Van Netten, J.J., Price, P.E., Lavery, L.A., Monteiro‐Soares, M., Rasmussen, A., Jubiz, Y., Bus, S.A. and International Working Group on the Diabetic Foot (IWGDF), 2016. Prevention of foot ulcers in the at‐risk patient with diabetes: a systematic review. Diabetes/metabolism research and reviews, 32, pp.84-98.
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Randomised Controlled Trials

Burns, J., Wegener, C., Begg, L., Vicaretti, M. and Fletcher, J., 2009. Randomized trial of custom orthoses and footwear on foot pain and plantar pressure in diabetic peripheral arterial disease. Diabetic medicine, 26(9), pp.893-899.
Click here for Article

Bus, S.A., Waaijman, R., Arts, M., De Haart, M., Busch-Westbroek, T., Van Baal, J. and Nollet, F., 2013. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes care, p.DC_130996.
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Cisneros, L.L., 2010. Evaluation of a neuropathic ulcers prevention program for patients with diabetes. Brazilian Journal of Physical Therapy, 14(1), pp.31-37.
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López-Moral, M., Lázaro-Martínez, J.L., García-Morales, E., Garcia-Alvarez, Y., Álvaro-Afonso, F.J. and Molines-Barroso, R.J., 2019. Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial. PloS one, 14(7).
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Reiber, G.E., Smith, D.G., Wallace, C., Sullivan, K., Hayes, S., Vath, C., Maciejewski, M.L., Yu, O., Heagerty, P.J. and LeMaster, J., 2002. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. Jama, 287(19), pp.2552-2558.
Click here for Article

Rizzo, L., Tedeschi, A., Fallani, E., Coppelli, A., Vallini, V., Iacopi, E. and Piaggesi, A., 2012. Custom-made orthesis and shoes in a structured follow-up program reduces the incidence of neuropathic ulcers in high-risk diabetic foot patients. The international journal of lower extremity wounds, 11(1), pp.59-64.
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Uccioli, L., Faglia, E., Monticone, G., Favales, F., Durola, L., Aldeghi, A., Quarantiello, A., Calia, P. and Menzinger, G., 1995. Manufactured shoes in the prevention of diabetic foot ulcers. Diabetes care, 18(10), pp.1376-1378.
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For orthotic interventions where large volumes of high quality evidence exist, lower levels of evidence have not been included in the Orthotics Evidence Portal.

Systematic Reviews

Paton, J., Hatton, A.L., Rome, K. and Kent, B., 2016. Effects of foot and ankle devices on balance, gait and falls in adults with sensory perception loss: a systematic review. JBI database of systematic reviews and implementation reports, 14(12), p.127.
Click here for Article

Cohort Studies

Aruin, A.S. and Rao, N., 2010. Ankle-foot orthoses: proprioceptive inputs and balance implications. Journal of prosthetics and orthotics: JPO, 22(4 Suppl), p.34.
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Renner, N., Wirth, S.H., Osterhoff, G., Böni, T. and Berli, M., 2016. Outcome after protected full weightbearing treatment in an orthopedic device in diabetic neuropathic arthropathy (Charcot arthropathy): a comparison of unilaterally and bilaterally affected patients. BMC musculoskeletal disorders, 17(1), p.504.
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Case Control Studies

Chakraborty, P.P., Ray, S., Biswas, D., Baidya, A., Bhattacharjee, R., Mukhopadhyay, P., Ghosh, S., Mukhopadhyay, S. and Chowdhury, S., 2015. A Comparative Study Between Total Contact Cast and Pressure-Relieving Ankle Foot Orthosis in Diabetic Neuropathic Foot Ulcers. Journal of Diabetes Science and Technology, 9(2), p.302.
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Case Series

Jani, M.M., Ricci, W.M., Borrelli, J., Barrett, S.E. and Johnson, J.E., 2003. A protocol for treatment of unstable ankle fractures using transarticular fixation in patients with diabetes mellitus and loss of protective sensibility. Foot & ankle international, 24(11), pp.838-844.
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Koller, A., Meissner, S.A., Podella, M. and Fiedler, R., 2007. Orthotic management of Charcot feet after external fixation surgery. Clinics in podiatric medicine and surgery, 24(3), pp.583-599.
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