Recruiting

Smart insoles to prevent foot ulcers in people with diabetes

Plain-English translation of NCT05950659 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing the Orpyx Sensory Insoles, special shoe inserts with built-in sensors that track pressure, temperature, and movement on your feet. The study will compare people who wear these smart insoles (along with their regular foot care) to people who receive standard foot care alone, to see if the insoles help prevent diabetic foot ulcers from returning.

Diabetic foot ulcers are a serious problem that often comes back after healing, sometimes leading to infection or amputation. This study wants to see if wearable technology that gives you real-time feedback about foot pressure and stress can catch problems early and prevent ulcers from developing in the first place.

Do you qualify?

You likely qualify if…

you have been diagnosed with type 1 or type 2 diabetes
you have nerve damage in your feet (confirmed by a simple test) due to diabetes
you had a diabetic foot ulcer on the bottom of your foot that healed completely within the last 12 months
you can walk independently for at least 30 steps, with or without a cane or walker
you are willing to wear the smart insoles for at least 5 hours per day while awake
you are 18 years or older

You likely don't qualify if…

you currently have an open foot ulcer or other open wound on your foot or leg
you have severe heart, lung, or balance problems that prevent you from walking 30 steps or standing for 5 minutes
you have dementia or a psychiatric condition that would make it difficult to follow the study instructions
you are currently enrolled in another study testing a similar foot-protection device
you have gangrene, bone infection, or severe foot deformities that would require surgery

What participation looks like

If you qualify, you'll be randomly assigned to either wear the Orpyx Sensory Insoles along with your regular diabetic foot care, or to continue with standard foot care alone. You'll need to wear the insoles during your daily activities and at home for at least 5 hours a day, and the sensors will track pressure and temperature patterns on your feet. The study will follow you over time to see whether the insoles help prevent new ulcers from forming and will ask you questions about your quality of life and whether you find the insoles helpful.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(1 site)

United States

Johns Hopkins Hospital, Baltimore, Maryland