MedTrace Logo

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

NCT07441772 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-02

No results posted yet for this study

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. 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).

Conditions

Interventions

DEVICE

Otoform toe divider

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

Sponsors & Collaborators

  • University of Huddersfield

    lead OTHER

Principal Investigators

  • John Stephenson · Huddersfield University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-03-31
Completion
2028-07-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441772 on ClinicalTrials.gov