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

Sponsor
University of Huddersfield
Study ID
NCT07441772
Status
Not Yet Recruiting

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Conditions

  • Amputation
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Not accepted

Interventions

  • Otoform toe divider — DEVICE
    Otoform is a moldable silicone used to make a toe divider.

Study Details

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 Dates

First listed
Mar 2, 2026
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    The study group will be given a toe divider
  • No Intervention: Control Arm
    Participants will continue to receive regular treatment.

Primary Outcome Measure

Acceptibility of wearing a toe divider [ Time Frame: From enrollment and then every 6 weeks for 52 weeks. ]

Central Contacts

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