TOE Study: Treatment and Gait Analysis fOllowing an Excised Lesser Toe

Starting soon · Not applicable

Conditions studied: Diabetes Mellitus, Amputation

In brief

Summary of study The study will examine patients with Diabetes Mellitus (DM) who have had a lesser toe amputations (LTA) (toes 2nd3rd,4th or 5th). It is currently not understood how this affects the way patients walk and foot function. No previous studies have been undertaken to examine this and its potential for causing further ulceration risk. This study is a feasibility study. It is designed to see if it is possible to undertake a large, randomised trial. It will explore how participants are recruited, kept in the study and how easy it is to follow the study protocol. Aim of the study Establish the feasibility of a corresponding full scale investigation into to the effectiveness of a toe divider made from Otoform for patients with DM following an LTA. Study Design 1. Participants will be recruited from Mid Yorkshire NHS teaching Hospital. 2. Participants will be randomised to receive either standard care or an otoform toe divider. 3. Participants age, gender, medical history, medication and blood sugar levels will be recorded. 4. Vascular and neurological assessments, foot posture and toe deformities will be undertaken and recorded. 5. All participants will have pressures measured on the plantar aspects of both feet. 6. Follow up visits will be arranged every 6 weeks for12 months for all participants to monitor foot health and changes in walking pattern and pressure redistribution. 7. If an ulceration or other foot complication occurs, the participants will be removed from the study and appropriate treatment given (the rescue arm of the study).

Key facts

Study ID

NCT07441772

Run by

University of Huddersfield

People needed

30

Starts

2026-04-01

Expected to finish

2028-07-31

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older, up to 105. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants over the age of 18.
• Participants with DM and a lesser toe amputation.
• Participants who wish to take part and provide informed written consent
• Participants who are mobile (including those who use walking aids).

You may not qualify if…

• Participants under the age of 18.
• Participants who do not have DM.
• Participants who have active ulcerations or surgical sites.
• Participants who had had a 1st toe and/or ray amputation.
• Participants with neuroarthropathy or other marked foot deformities.
• Participants who already wear a toe divider.
• Participants who have a known allergy to the silicone or catalyst being used.
• Participants who are immobile.

Full record on ClinicalTrials.gov

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