TOE Study: Treatment and gait analysis fOllowing an Excised lesser toe
Research type
Research Study
Full title
A feasibility study to examine the effect of Otoform toe dividers in the treatment of patients with diabetes mellitus following a lesser toe amputation
IRAS ID
364590
Contact name
John Stephenson
Contact email
Sponsor organisation
University of Huddersfield
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
n/a,
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Why this study is being done
People with diabetes sometimes need to have one of their smaller toes (the 2nd, 3rd, 4th, or 5th) removed. This can change how they walk and how pressure is spread across their feet, which may increase the risk of foot sores (ulcers). We don’t yet know enough about how these changes happen or how best to protect the foot afterwards.
What the study aims to find out
This study will test whether a toe divider made from Otoform is comfortable and helpful for people who’ve had a smaller toe amputated. It will also see if the toe divider changes how pressure is spread under the foot when walking.
What will happen
• Adults with diabetes who have lost one of the smaller toes will be invited to take part.
• Some people will receive routine care only, while others will also be given an Otoform toe divider.
• We’ll collect some health details and check blood flow, nerve function, and foot shape.
• Special tests will measure walking patterns and foot pressure at the start and during follow-up visits every 6 weeks for up to a year.
• If a participant develops a sore or another problem, they’ll stop taking part and receive normal treatment.
What we hope to learn
We want to find out if the Otoform toe divider is:
• Comfortable and accepted by patients, and
• Helpful in reducing foot pressures and preventing new ulcers.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
26/YH/0028
Date of REC Opinion
24 Apr 2026
REC opinion
Further Information Favourable Opinion