Recruiting

Testing Smart Boots to Help Diabetic Foot Ulcer Healing

Plain-English translation of NCT04460573 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study helps people with diabetes who have developed foot ulcers (open sores that won't heal on their own). You'll wear a special diabetic boot designed to take pressure off your foot while it heals. The researchers want to compare three different boot approaches — one that asks you to wear it constantly, one that lets you remove it at night, and one with a smart device that reminds you to wear it and tracks how often you do.

Diabetic foot ulcers can lead to amputation if not treated properly, and wearing an offloading boot is a key part of healing. However, many patients don't wear their boots as often as they should. This trial tests whether new technology and different approaches can help people stick with wearing their boots, which could help wounds heal faster and prevent serious complications.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with a diabetic foot ulcer that is not infected and does not have poor blood flow
you are able to walk at home, with or without help
you are willing and able to give written consent to participate
your ulcer has been present for less than 1 year

You likely don't qualify if…

you have very poorly controlled diabetes (HbA1c over 12%)
you have severe blood flow problems in your affected leg
you have acute Charcot neuropathy or a major foot deformity that prevents you from wearing the boot
you have already had an amputation above the ankle on the affected leg
you have recently changed psychiatric or sleep medications (within 6 weeks)

What participation looks like

You'll be randomly assigned to one of three boot groups. You'll wear your assigned boot for the duration of the study and come to clinic visits to check your healing progress. Depending on your group, you might wear the boot all the time (including at night), wear it only during walking and standing, or wear a boot with a smartwatch that reminds you to put it on and tracks your usage. The researchers will also ask you about your activity level, sleep quality, and how you feel overall.

Testing Smart Boots to Help Diabetic Foot Ulcer Healing

What is this trial?

Do you qualify?

What participation looks like

Trial locations(4 sites)