Wearable insoles warn of foot pressure to stop diabetic ulcers

NCT ID NCT07674420

Ongoing Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

First seen Jun 29, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This trial tests a wearable insole system that monitors foot pressure, temperature, and movement, giving real-time alerts to help users shift weight and avoid injury. The study includes people with type 1 or 2 diabetes who have nerve damage and a recent history of healed foot ulcers. Researchers want to see if using these smart insoles alongside standard care reduces the chance of ulcers coming back.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Orpyx Sensory Insole System
What this could lead to: If effective, these insoles could help prevent painful foot ulcers in people with diabetes, reducing hospital visits and amputations.
What could go wrong: This is a small early study with only 17 participants, so results may not apply broadly. The insoles may not prevent all ulcers or could be inconvenient to wear.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot peripheral nervous system disorder peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DIABETES DIABETIC FOOT ULCER PERIPHERAL NEUROPATHY

Contacts and locations

Locations

Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States

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