Health Technology/clinical-trials

Phase IV Trial Opens: Orpyx Smart Insoles vs Standard Care for Diabetic Foot Ulcer Prevention — What Clinicians Need to Know

247 Health News Editorial

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26 May 2026

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4 min read

·clinical-trials

New multisite trial tests smart insole technology for preventing diabetic foot ulcer recurrence in high-risk patients. The Orpyx Sensory Insole System provides real-time pressure monitoring and feedback, potentially transforming diabetic foot care from reactive to proactive prevention.

Originally reported by ClinicalTrials.gov

References

  1. 1.Orpyx Medical Technologies Inc. (2023). Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System. ClinicalTrials.gov. NCT05950659. https://clinicaltrials.gov/study/NCT05950659
  2. 2.Najafi, B., Mohseni, H., Grewal, G. S., Talal, T. K., Menzies, R. A., & Lavery, L. A. (2017). An optical-fiber-based smart textile (smart socks) to manage biomechanical risk factors associated with diabetic foot amputation. Journal of Diabetes Science and Technology, 11(4), 668-677. https://doi.org/10.1177/1932296817695338
  3. 3.Armstrong, D. G., Boulton, A. J., & Bus, S. A. (2017). Diabetic foot ulcers and their recurrence. New England Journal of Medicine, 376(24), 2367-2375. https://doi.org/10.1056/NEJMra1615439
  4. 4.Bus, S. A., Lavery, L. A., Monteiro‐Soares, M., Rasmussen, A., Raspovic, A., Sacco, I. C., & van Netten, J. J. (2020). Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2019 update). Diabetes/Metabolism Research and Reviews, 36(1), e3269. https://doi.org/10.1002/dmrr.3269
  5. 5.Kerr, M., Barron, E., Chadwick, P., Evans, T., Kong, W. M., Rayman, G., & Jeffcoate, W. J. (2019). The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabetic Medicine, 36(8), 995-1002. https://doi.org/10.1111/dme.13973
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247 Health News Editorial

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