Evidence for orthotic treatment of the active (neuroarthropathy / Charcot) diabetic foot

The orthotics evidence portal
NHS GGC

Presence of active ulceration, infection, with or without ischaemia, gangrene or unexplained hot, red, swollen foot with or without the presence of pain.

(*Categories per the Scottish Foot Action Group, relating to the use of the SCI-Diabetes foot risk stratification tool)

Walker boot

Meta Analyses

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

Morona, J.K., Buckley, E.S., Jones, S., Reddin, E.A. and Merlin, T.L., 2013. Comparison of the clinical effectiveness of different off‐loading devices for the treatment of neuropathic foot ulcers in patients with diabetes: a systematic review and meta‐analysis. Diabetes/metabolism research and reviews, 29(3), pp.183-193.
Click here for Article

Systematic Reviews

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.
Click here for Article

Lewis, J. and Lipp, A., 2013. Pressure‐relieving interventions for treating diabetic foot ulcers. Cochrane Database of Systematic Reviews, (1).
Click here for Article

Madmoli, M., Madmoli, Y., Khodadadi, M. and Samsamipour, M., 2019. Study of Some Effective Treatments for Accelerating Diabetic Foot Ulcer Healing: A Systematic Review. International Journal of Research Studies in Science, Engineering and Technology, 6(2), pp.34-39.
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Randomised Controlled Trials

Armstrong, D.G., Lavery, L.A., Wrobel, J.S. and Vileikyte, L., 2008. Quality of life in healing diabetic wounds: does the end justify the means?. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 47(4), p.278.
Click here for Article

Armstrong, D.G., Lavery, L.A., Wu, S. and Boulton, A.J., 2005. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes care, 28(3), pp.551-554.
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Armstrong, D.G., Nguyen, H.C., Lavery, L.A., Van Schie, C.H., Boulton, A.J. and Harkless, L.B., 2001. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes care, 24(6), pp.1019-1022.
Click here for Article

Bus, S.A., van Netten, J.J., Kottink, A.I., Manning, E.A., Spraul, M., Woittiez, A.J. and van Baal, J.G., 2018. The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single‐blinded multicentre randomised controlled trial. International wound journal, 15(1), pp.65-74.
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Caravaggi, C., Sganzaroli, A., Fabbi, M., Cavaiani, P., Pogliaghi, I., Ferraresi, R., Capello, F. and Morabito, A., 2007. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Diabetes Care, 30(10), pp.2577-2578.
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Faglia, E., Caravaggi, C., Clerici, G., Sganzaroli, A., Curci, V., Vailati, W., Simonetti, D. and Sommalvico, F., 2010. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes care, 33(7), pp.1419-1423.
Click here for Article

Katz, I.A., Harlan, A., Miranda-Palma, B., Prieto-Sanchez, L., Armstrong, D.G., Bowker, J.H., Mizel, M.S. and Boulton, A.J., 2005. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care, 28(3), pp.555-559.
Click here for Article

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.
Click here for Article


For orthotic interventions where large volumes of high quality evidence exist; lower levels of evidence have not been included in the Orthotics Evidence Portal.

Cast

Meta Analyses

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

Morona, J.K., Buckley, E.S., Jones, S., Reddin, E.A. and Merlin, T.L., 2013. Comparison of the clinical effectiveness of different off‐loading devices for the treatment of neuropathic foot ulcers in patients with diabetes: a systematic review and meta‐analysis. Diabetes/metabolism research and reviews, 29(3), pp.183-193.
Click here for Article

Systematic Reviews

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.
Click here for Article

Lewis, J. and Lipp, A., 2013. Pressure‐relieving interventions for treating diabetic foot ulcers. Cochrane Database of Systematic Reviews, (1).
Click here for Article

Randomised Controlled Trials

Armstrong, D.G., Lavery, L.A., Wrobel, J.S. and Vileikyte, L., 2008. Quality of life in healing diabetic wounds: does the end justify the means?. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 47(4), p.278.
Click here for Article

Armstrong, D.G., Nguyen, H.C., Lavery, L.A., Van Schie, C.H., Boulton, A.J. and Harkless, L.B., 2001. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes care, 24(6), pp.1019-1022.
Click here for Article

Bus, S.A., van Netten, J.J., Kottink, A.I., Manning, E.A., Spraul, M., Woittiez, A.J. and van Baal, J.G., 2018. The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single‐blinded multicentre randomised controlled trial. International wound journal, 15(1), pp.65-74.
Click here for Article

Caravaggi, C., Faglia, E., De Giglio, R., Mantero, M., Quarantiello, A., Sommariva, E., Gino, M., Pritelli, C. and Morabito, A., 2000. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes care, 23(12), pp.1746-1751.
Click here for Article

Caravaggi, C., Sganzaroli, A., Fabbi, M., Cavaiani, P., Pogliaghi, I., Ferraresi, R., Capello, F. and Morabito, A., 2007. Nonwindowed nonremovable fiberglass off-loading cast versus removable pneumatic cast (AircastXP Diabetic Walker) in the treatment of neuropathic noninfected plantar ulcers: a randomized prospective trial. Diabetes Care, 30(10), pp.2577-2578.
Click here for Article

Faglia, E., Caravaggi, C., Clerici, G., Sganzaroli, A., Curci, V., Vailati, W., Simonetti, D. and Sommalvico, F., 2010. Effectiveness of removable walker cast versus nonremovable fiberglass off-bearing cast in the healing of diabetic plantar foot ulcer: a randomized controlled trial. Diabetes care, 33(7), pp.1419-1423.
Click here for Article

Jeffcoate, W., Game, F., Turtle-Savage, V., Musgrove, A., Price, P., Tan, W., Bradshaw, L., Montgomery, A., Fitzsimmons, D., Farr, A. and Winfield, T., 2017. Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial. Health technology assessment (Winchester, England), 21(34), p.1.
Click here for Article

Katz, I.A., Harlan, A., Miranda-Palma, B., Prieto-Sanchez, L., Armstrong, D.G., Bowker, J.H., Mizel, M.S. and Boulton, A.J., 2005. A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers. Diabetes Care, 28(3), pp.555-559.
Click here for Article

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.
Click here for Article

Miyan, Z., Ahmed, J., Zaidi, S.I., Ahmedani, M.Y., Fawwad, A. and Basit, A., 2014. Use of locally made off‐loading techniques for diabetic plantar foot ulcer in Karachi, Pakistan. International wound journal, 11(6), pp.691-695.
Click here for Article

Piaggesi, A., Macchiarini, S., Rizzo, L., Palumbo, F., Tedeschi, A., Nobili, L.A., Leporati, E., Scire, V., Teobaldi, I. and Del Prato, S., 2007. An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast. Diabetes care, 30(3), pp.586-590.
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Van De Weg, F.B., Van Der Windt, D.A.W.M. and Vahl, A.C., 2008. Wound healing: total contact cast vs. custom-made temporary footwear for patients with diabetic foot ulceration. Prosthetics and orthotics international, 32(1), pp.3-11.
Click here for Article


For orthotic interventions where large volumes of high quality evidence exist, lower levels of evidence have not been included in the Orthotics Evidence Portal.

Editorial Information

Last reviewed: 01/08/2024

Next review date: 01/08/2025

Approved By: British Association of Prosthetists and Orthotists (BAPO)

Reviewer name(s): Laura Barr, British Association of Prosthetists and Orthotists (BAPO) Professional Affairs Committee .