Could a simple silicone toe divider prevent foot ulcers after amputation?

NCT ID NCT07441772

Not yet recruiting Knowledge-focused Sponsor: University of Huddersfield Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a moldable silicone toe divider (Otoform) can help people with diabetes who have had a lesser toe amputated. Researchers want to see if it is possible to run a larger trial by testing how well patients accept the device and how it affects walking and foot pressure. Thirty participants will be randomly assigned to standard care or the toe divider and followed for 12 months.

What this could mean

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

Active substance: Otoform toe divider (moldable silicone device)
What this could lead to: If this small study shows the toe divider is acceptable and easy to use, it could pave the way for a larger trial to see if it prevents foot ulcers after toe amputation in people with diabetes.
What could go wrong: This is a very early feasibility study with only 30 participants, so it cannot prove the device works. It is designed to test whether a bigger trial is even possible, not to measure health outcomes.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus

As listed by the trial registrant

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

AMPUTATION DIABETES MELLITUS

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