Health Technology/clinical-trials

Wearable Sensory Insole Technology Trialled for Recurrent Diabetic Foot Ulcer Prevention — What Clinicians Need to Know

247 Health News Editorial

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16 July 2026

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4 min read

·clinical-trials

A Johns Hopkins University-sponsored pilot trial is evaluating the Orpyx SI Sensory Insole System as an adjunct to standard care for preventing recurrent plantar diabetic foot ulcers in high-risk patients with peripheral neuropathy. The study targets a critical unmet need, given that ulcer recurrence rates reach 40% within one year of healing. Clinicians in endocrinology, podiatry, and vascular surgery should monitor this trial's findings closely.

Originally reported by ClinicalTrials.gov

References

  1. 1.Johns Hopkins University. (2025). Wearable insoles for recurrent diabetic ulcer prevention (NCT07674420). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT07674420
  2. 2.Pop-Busui, R., Boulton, A. J. M., Feldman, E. L., Bril, V., Freeman, R., Malik, R. A., Sosenko, J. M., & Ziegler, D. (2017). Diabetic neuropathy: A position statement by the American Diabetes Association. Diabetes Care, 40(1), 136–154. https://doi.org/10.2337/dc16-2042
  3. 3.Armstrong, D. G., Boulton, A. J. M., & 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.Boulton, A. J. M., Vileikyte, L., Ragnarson-Tennvall, G., & Apelqvist, J. (2005). The global burden of diabetic foot disease. The Lancet, 366(9498), 1719–1724. https://doi.org/10.1016/S0140-6736(05)67698-2
  5. 5.Najafi, B., Reeves, N. D., & Armstrong, D. G. (2019). Leveraging smart technologies to improve the management of diabetic foot ulcers and extend ulcer-free days in remission. Diabetes/Metabolism Research and Reviews, 35(4), e3158. https://doi.org/10.1002/dmrr.3158
  6. 6.Bus, S. A., Lavery, L. A., Monteiro-Soares, M., Rasmussen, A., Raspovic, A., Sacco, I. C. N., & 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(S1), e3269. https://doi.org/10.1002/dmrr.3269
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