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

NCT ID NCT07441772

Knowledge-focused Sponsor: University of Huddersfield Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 105 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants over the age of 18. 2. Participants with DM and a lesser toe amputation. 3. Participants who wish to take part and provide informed written consent 4. Participants who are mobile (including those who use walking aids). Exclusion Criteria 1. Participants under the age of 18. 2. Participants who do not have DM. 3. Participants who have active ulcerations or surgical sites. 4. Participants who had had a 1st toe and/or ray amputation. 5. Participants with neuroarthropathy or other marked foot deformities. 6. Participants who already wear a toe divider. 7. Participants who have a known allergy to the silicone or catalyst being used. 8. Participants who are immobile.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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