Smarter Sole Survival: Will Neuropathic Patients at High Risk for Ulceration Use a Smart Insole-Based Foot Protection System?
Open accessAbstract
Objective: This study examined adherence to alert-based cues for plantar pressure offloading in patients with diabetic foot disease. Method and Design: Participants (n = 17) with in diabetic foot remission (history of neuropathic ulceration) were instructed to wear a smart insole system (the SurroSense Rx, Orpyx Medical Technologies Inc, Calgary, Canada) over a three-month period. This device is designed to cue offloading to manage unprotected sustained plantar pressures in an effort to prevent foot ulceration. A successful response to an alert was defined as pressure offloading, which occurred within 20 minutes of the alert onset. Patient adherence, defined as daily hours of device wear, was determined using sensor data and patient questionnaires. Changes in these parameters were assessed monthly. Results: Patients demonstrating increased adherence over the course of the study received more alerts (0.82 ± 0.31 alerts/hour) than patients whose adherence did not improve (0.36 ± 0.46 alerts/hour, P = .156). By the final stages of the study, participants who had received at least one alert every two hours were more adherent with offloading than participants who received fewer alerts (52.5 ± 4.1% vs 24.7 ± 22.4%, P = .043). Furthermore, duration of time from alert generation to successful offloading was significantly greater in the group receiving fewer alerts. This was measured in the third month with an effect size Cohen’s d = 1.739, P = .043. Conclusion: The results suggest a minimum number of alerts (one every two hours) is required for patients with diabetic neuropathy to optimally respond to offloading cues from a smart insole system.
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The SurroGait Rx device has been successful for pressure-offloading alerts to prevent diabetic foot ulcers.
“This device has also been successful for pressure-offloading alerts to prevent diabetic foot ulcers, which cost the US$81.7 billion in 2012 [104,105].”
From Wearables and the Medical Revolution (2018) · cites this paper as [105]
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BackgroundMethodResultInfluentialSelf-citationMobility advice to help prevent re‐ulceration in diabetes
Mueller, M. J. (2019) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3259 · Cited by 16 · see citing works
“Technology and activity monitors may help measure stress during standing and walking, provide warnings to patients when they are approaching their typical daily static and dynamic weight-bearing levels, and help to prevent problems.(8,12,25) Monitoring plantar skin temperatures was introduced many years ago by Brand(2…”
BackgroundMacdonald, E. M., Perrin, B., & Kingsley, M. (2020) · Journal of Foot and Ankle Research · doi:10.1186/s13047-020-00396-x · Cited by 16 · see citing works
Macdonald, E. M., Perrin, B., Cleeland, L., & Kingsley, M. (2021) · Sensors · doi:10.3390/s21123984 · Cited by 16 · see citing works
“[12], who found that participants who received significantly fewer alerts per hour compared to the current study had positive adoption intentions towards a similar device at the end of a three-month trial.”
BackgroundResultInfluentialGurney, J., Kersting, U. G., Rosenbaum, D., Dissanayake, A. M., York, S., Grech, R., Ng, A. C.-K., Milne, B., Stanley, J., & Sarfati, D. (2017) · Journal of Foot and Ankle Research · doi:10.1186/s13047-017-0205-6 · Cited by 16 · see citing works
Diabetic Foot Considerations Related to Plantar Pressures and Shear
Martin, J. K., & Davis, B. L. (2023) · Foot and Ankle Clinics · doi:10.1016/j.fcl.2022.11.004 · Cited by 15 · see citing works
Adherence and the Diabetic Foot: High Tech Meets High Touch?
Srass, H., Ead, J. K., & Armstrong, D. G. (2023) · Sensors · doi:10.3390/s23156898 · Cited by 15 · see citing works
Self-citationThe quest for wellness: How to optimise self‐care strategies for diabetic foot management?
Pouwer, F., Perrin, B., Lavender, A., Najafi, B., Ismail, K., & Vileikytė, L. (2023) · Diabetes/Metabolism Research and Reviews · doi:10.1002/dmrr.3751 · Cited by 14 · see citing works
“29 Another prospective, randomised clinical trial of an intelligent pressure ‐ sensing system? demonstrated 71% reduction in DFU recurrence in the intervention as compared to the control group.”
BackgroundMethodInfluentialSelf-citationDigital foot health technology and diabetic foot monitoring: A systematic review
Thorne, C. S., Gatt, A., Raffaele, C. D., Bazena, A., & Formosa, C. (2021) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2021.108783 · Cited by 13 · see citing works
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“proposed the concept of smart insoles in people with a history of DFU and found users who received one alert every two hours were significantly more adherent to use their prescribed footwear [21].”
BackgroundSelf-citationNg, G. W., Gan, K. F., Liew, H., Ge, L., Ang, G. Y., Molina, J. A. D. C., Sun, Y., Prakash, P. S., Harish, K. B., & Lo, Z. J. (2024) · The International Journal of Lower Extremity Wounds · doi:10.1177/15347346241233962 · Cited by 12 · see citing works
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Static and dynamic optimisation of fluid-filled responsive orthotic insoles
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“…et al. 2020; Gothard and Anton 2021; Samarentsis et al. 2022; Kim et al. 2022; Gothard et al. 2023; Willemstein et al. 2023; Macdonald et al. 2021; Najafi et al. 2017; Bus et al. 2011), and functionally graded designs that reduce peak plantar pressure by between 16% (Hudak et al. 2022) and 48%…”
Obilor, H. N., Achore, M., & Woo, K. Y. (2021) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2021.11.009 · Cited by 12 · see citing works
Mallakpour, S. E., Radfar, Z., & Hussain, C. M. (2024) · Elsevier eBooks · doi:10.1016/b978-0-323-95383-2.00015-9 · Cited by 9 · see citing works
Subscription prescription: remote patient monitoring using smart shoes, socks and insoles
Armstrong, D. G. (2019) · Journal of Wound Care · doi:10.12968/jowc.2019.28.sup9.s3 · Cited by 9 · see citing works
Self-citationNovel technologies for detection and prevention of diabetic foot ulcers
Reeves, N. D., Cassidy, B., Abbott, C. A., & Yap, M. H. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-821070-3.00007-6 · Cited by 9 · see citing works
Chatwin, K. E., Abbott, C. A., Reddy, P. N., Bowling, F. L., Boulton, A. J. M., & Reeves, N. D. (2018) · The International Journal of Lower Extremity Wounds · doi:10.1177/1534734618784080 · Cited by 9 · see citing works
Assessment of Validity and Reliability of Plantar Pressure in Smart Insole
Kang, H. W., An, Y. L., Kim, D.-Y., et al. (2022) · Journal of Korean Foot and Ankle Society · doi:10.14193/jkfas.2022.26.3.130 · Cited by 8 · see citing works
An overview of current developments and methods for identifying diabetic foot ulcers: A survey
Anbarasi, L. J., Jawahar, M., Jayakumari, R. B., Narendra, M., Ravi, V., & Neeraja, R. (2024) · Wiley Interdisciplinary Reviews Data Mining and Knowledge Discovery · doi:10.1002/widm.1562 · Cited by 7 · see citing works
“One promising approach involves the use of smart insoles embedded with pressure sensors and temperature monitors (Najafi et al., 2017).”
Devanand, D. B., Gardiner, M. D., & Kedgley, A. E. (2025) · Sensors · doi:10.3390/s25051352 · Cited by 6 · see citing works
“The following supporting information can be downloaded at: https: //www.mdpi.com/article/10.3390/s25051352/s1, Table S1: Participant demographics; Table S2: Force sensing resistor wear time estimations; Table S3: Force sensing resistor device accuracy; Table S4: Force sensing resistor percentage agreement vs. sampling…”
InfluentialA Review on Newer Interventions for the Prevention of Diabetic Foot Disease
Tekale, S., Varma, A. R., Tekale, S., & Kumbhare, U. (2022) · Cureus · doi:10.7759/cureus.30591 · Cited by 6 · see citing works
“When persistent pressure is found, the wearer sees a pressure mapping of each foot showing the area of prolonged stress and hears an alert (pressure greater than 35-50 mmHg and continuing for 15 minutes) [37].”
BackgroundMethodInfluentialMcDonogh, C., Nubé, V. L., Frank, G., Twigg, S. M., Penkala, S., Holloway, S., & Snyder, R. (2022) · Journal of Foot and Ankle Research · doi:10.1186/s13047-022-00600-0 · Cited by 8 · see citing works
“A further limitation of this study was that plantar pressures were measured in a controlled clinical setting that may not reflect the cumulative forces a patient is subject to over a day [28, 34].”
BackgroundLazarus, J., Cioroianu, I., Ehrhardt, B., Gurevich, D., Kreußer, L. M., Metcalfe, B., Nishtala, P. S., Preatoni, E., & Sharp, T. H. (2023) · Frontiers in Clinical Diabetes and Healthcare · doi:10.3389/fcdhc.2023.1212182 · Cited by 8 · see citing works
“(79) reports average scores of over four in a five point-scale for comfort and benefit for their insole sensors.”
BackgroundSmart Technology for the Diabetic Foot in Remission
Najafi, B., & Armstrong, D. G. (2020) · Wiley eBooks · doi:10.1002/9781119445821.ch12 · Cited by 6 · see citing works
Self-citationDigital foot care—leveraging digital health to extend ulcer-free days in remission
Najafi, B., Swerdlow, M., Murphy, G. A., & Armstrong, D. G. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-817485-2.00013-4 · Cited by 5 · see citing works
Self-citationCorser, J., Yoldi, I., Reeves, N. D., Culmer, P., Venkatraman, P. D., Orlando, G., Turnbull, R. P., Boakes, P., Woodin, E., Lightup, R., et al. (2025) · Journal of Participatory Medicine · doi:10.2196/59608 · Cited by 4 · see citing works
“…into smart sensing wearables for plantar pressure has found that a minimum number of alerts (1 every 2 hours) is required for optimum response [40], whereas this study suggests that, for shear strain, if the alerts are perceived as too frequent and there is no clear resolvable issue in the…”
Barsotti, E. J., Goodman, B., Samuelson, R. J., et al. (2024) · Journal of Diabetes Science and Technology · doi:10.1177/19322968241231279 · Cited by 3 · see citing works
Smart Insoles a Cutting Edge Technology in the Field of Orthotics: A Review
Kumar, Y., & ., R. (2024) · International Journal of Health Sciences and Research · doi:10.52403/ijhsr.20240441 · Cited by 3 · see citing works
“In particular, it is supposed to be small, low-powered actuators and sensors would play critical roles in smart systems and smart devices in the era of the internet-of-things (IoT) and internet-of-everything (IoE) 26 .”
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Yeh, T.-T., Huang, J.-S., & Chou, Y.-C. (2025) · Journal of Foot and Ankle Research · doi:10.1002/jfa2.70051 · Cited by 5 · see citing works
“Emerging home‐monitoring technologies include intelligent smart socks [19–21], smart insoles [22, 23], and smart mats [24].”
Elumalai, M., Childs, A., Williams, S. K., Arguello, G., Martinez, E., Easterling, A., Luis, D. S., Rajaraman, S., & Didier, C. M. (2025) · Micromachines · doi:10.3390/mi16070804 · Cited by 3 · see citing works
“Although emerging technologies such as pressure-sensing insoles or smart footwear exist, they are not reliably covered by current reimbursement structures [11,44–49].”
López‐Moral, M., Molines-Barroso, R. J., Herrera-Casamayor, M., et al. (2023) · The International Journal of Lower Extremity Wounds · doi:10.1177/15347346231190680 · Cited by 2 · see citing works
Yin, C., Mpofu, E., Brock, K. E., et al. (2024) · Journal of Gerontological Nursing · doi:10.3928/00989134-20240110-05 · Cited by 2 · see citing works
The Diabetic Foot in Remission
Khan, T., Bus, S. A., Boulton, A. J. M., et al. (2020) · doi:10.1002/9781119445821.ch25 · Cited by 2 · see citing works
Self-citationKumar, K., Kabir, M. A., Donnan, L., & Ahmed, S. (2026) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-026-03349-9 · Cited by 1 · see citing works
“Knowledge-based systems build on this foundation by applying predefined rules and continuous monitoring for adherence and biomechanical safety [30, 46].”
Development of a Smart Insole for Baropodometric and Gait Analysis
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Foot Deformity and Pressure Management in the Diabetic Foot
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Accessible Design for Diabetic Foot Ulcer Self-Monitoring: Insights into mHealth Application Design
Bondu, M. T., Baseman, C. M., & Arriaga, R. I. (2024) · ACM International Joint Conference on Pervasive and Ubiquitous Computing (UbiComp) · doi:10.1145/3675094.3677580 · Cited by 1 · see citing works
“Given the nature of this potentially severe condition, diabetic foot care technology has been developed ranging from sensing systems that mitigate the risk of ulcer development [35] to wearable technologies, such as smart sole systems [26].”
Treatment of diabetic peripheral neuropathy: technologies, exercise, and alternative treatments
Pafili, K., & Παπάνας, Ν. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-820669-0.00008-6 · Cited by 1 · see citing works
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EMPLOYEE HEALTH MONITORING SYSTEM USING SMART INSOLES
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“Two published studies were identified which were using in-shoe pressure feedback technology; a validation study [9] and a pilot prospective cohort study with people with history of diabetic foot ulcer [10] however we found no research using devices in the management of active diabetic foot ulcers.”
Diabetic foot: Footwear in a management programme
Paavana, T., Crooks, S. A., & Hariharan, K. (2023) · International Journal of Orthopaedic Surgery · doi:10.4103/ijors.ijors_23_23
Health and biosensor technology—A revolution underway for the well-being of the population
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Chopra, D., Seth, N., Mohsin, N., & Lev‐Tov, H. A. (2024) · Springer eBooks · doi:10.1007/978-3-031-69091-4_6
Yeh, T., Huang, J.-S., & Wu, Y. (2025) · doi:10.2196/preprints.81401
Thorne, C. S., Gatt, A., Raffaele, C. D., et al. (2026) · The International Journal of Lower Extremity Wounds · doi:10.1177/15347346261428561
Wei, D., Li, B., Wang, J. R., & Gao, L. (2026) · Healthcare · doi:10.3390/healthcare14060780
“Cluster 8 (Wound nursing and therapy evaluation) Organized around “wound care” (28) and “efficacy” (55), linked with “therapy” (102) and novel approaches such as “cold atmospheric plasma” (5).”
InfluentialMizzi, S., Mifsud, T., Mizzi, A., Borg, M. G., Farrugia, R., & Falzon, O. (2026) · Sensors · doi:10.3390/s26072119 · Cited by 1 · see citing works
“For example, Najafi et al. [7] demonstrated the feasibility of smart textile systems during gait, while Billings et al. [8] evaluated temperature responses using a smart compression sock across multiple activities.”
Mrkić, F., Milić, L., Kojić, S., Petrović, B., Putnik, I., Qureshi, S., Enríquez-Schmidt, J., & Stojanović, G. M. (2026) · Textile Research Journal · doi:10.1177/00405175251397603
Chatwin, K. E., Abbott, C. A., Rajbhandari, S. M., Orlando, G., Bowling, F. L., Boulton, A. J. M., & Reeves, N. D. (2026) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2026.113293
Giurato, L., Scatena, A., Giglio, R. D., Murdolo, G., Mastinu, M., Gicchino, M., Gabriele, D., Vermigli, C., Panunzi, A., Uccioli, L., et al. (2026) · Acta Diabetologica · doi:10.1007/s00592-026-02722-4
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Wearable Technologies for Diabetic Foot Ulcer Monitoring and Risk Prediction: Systematic Review
Ehtemam, H., Salehinejad, S., ROBBINS, D. W., Sanaei, A., Shirvani, H., & Esfahlani, S. S. (2026) · JMIR Diabetes · doi:10.2196/84463 · Cited by 2 · see citing works
“The evidence shows that most wearable or insole-based pressure sensor studies include patients with diabetes, reflecting a practical research approach targeting those who will most benefit from early detection of increased plantar pressure or temperature changes [87].”
Digital Health Approaches to Geriatric Rehabilitation: A Narrative Paper
Moon, C., Bregasi, P., Khandan, A., & Najafi, B. (2026) · Annals of Rehabilitation Medicine · doi:10.5535/arm.260007
“Users of smart pressure monitoring insoles, for example, rated the systems as practical, enjoyable, and suitable for integration into daily routines, reflecting both ergonomic design and func‑ tional relevance [69].”
InfluentialSelf-citationYeh, T., Huang, J.-S., & Wu, Y. (2026) · Digital Health · doi:10.1177/20552076261479447
“8 These include smart socks for temperature-based monitoring, 9,10 smart insole systems for pressure monitoring and foot protection, 11–13 and smart mat platforms designed to identify early signs of plantar injury.”
Digital Technologies and Diabetic Footcare
Brown, S. J., Reeves, N. D., & Boulton, A. J. M. (2026) · Springer eBooks · doi:10.1007/978-3-032-24854-1_22
- Authors
- Najafi, B., Ron, E., Enriquez, A., Marin, I., Razjouyan, J., & Armstrong, D. G.
- Affiliations
- University of Arizona (US)
- Corresponding author
- Najafi, Bijan
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2017-01-30
- Volume
- 11
- Issue
- 4
- Pages
- 702-713
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC5588829
- OpenAlex
- W2582631007
- Semantic Scholar
- fdaef3fc8b6c8b6bdc96a9fd711166e681ec92a6
- Cited by
- 100
- References
- 49
- Citations by year
- 2026: 12 · 2025: 7 · 2024: 13 · 2023: 11 · 2022: 16 · 2021: 12 · 2020: 9 · 2019: 8 · 2018: 10 · 2017: 2
- FWCI
- 6.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Orpyx Medical Technologies Inc. (NA)
- Flinn Foundation (1907)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Physical Sciences › Engineering › Biomedical Engineering › Prosthetics and Rehabilitation Robotics
- Physical Sciences › Engineering › Biomedical Engineering › Lower Extremity Biomechanics and Pathologies
- Keywords
- smart insoles, diabetic foot, diabetic neuropathy, foot ulcer prevention, device adherence, pressure sensors, foot protection
- MeSH terms
- Wearable Electronic Devices, Female, Foot, Humans, Male, Patient Compliance, Pressure, Prospective Studies, Protective Devices, Cohort Studies, Diabetic Foot, Computers, Handheld
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