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

NCT07441772 | Not Yet Recruiting

• 1 other identifier: SREIC/2024/047
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Participants will be recruited from Mid Yorkshire NHS teaching Hospital.
2. 2.Participants will be randomised to receive either standard care or an otoform toe divider.
3. 3.Participants age, gender, medical history, medication and blood sugar levels will be recorded.
4. 4.Vascular and neurological assessments, foot posture and toe deformities will be undertaken and recorded.
5. 5.All participants will have pressures measured on the plantar aspects of both feet.
6. 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. 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).

Conditions

Diabetes Mellitus; Amputation

Keywords

Diabetes Mellitus, Lesser Toe Amputation

Outcome Measures

Primary Outcomes (1)

• Acceptibility of wearing a toe divider

  theoretical frame work of acceptability questionnaire

  From enrollment and then every 6 weeks for 52 weeks.

Secondary Outcomes (4)

• Peak Pressure

  From enrollment and then every 6 weeks for 52 weeks.

• Pressure time integral

  From enrollment and then every 6 weeks for 52 weeks.

• Contact Area

  From enrollment and then every 6 weeks for 52 weeks.

• Foot Posture Index

  From enrollment and then every 6 weeks for 52 weeks.

Study Arms (2)

Study Arm

EXPERIMENTAL

The study group will be given a toe divider

Device: Otoform toe divider

Control Arm

NO INTERVENTION

Participants will continue to receive regular treatment.

Interventions

Otoform toe divider DEVICE

Otoform is a moldable silicone used to make a toe divider.

Study Arm

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Huddersfield: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• John Stephenson

  Huddersfield University

  STUDY DIRECTOR

Central Study Contacts

Abigail R Dagg

CONTACT

07904456874; abigail.dagg@hud.ac.uk

Abigail R Dagg

CONTACT

07904456874; abigail.dagg@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study group will receive a prosthetic toe. Control group will receive standard care

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share