TerminatedNot Applicable

Prevention of Primary Foot Ulcers in High-risk Diabetes Patients

Stopped: Funding during the pandemic

United Kingdom900 participantsStarted 2019-09-01

Plain-language summary

This is a primary prevention study which aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of diabetes (type 1 or 2) * Aged ≥18 * Peripheral sensory neuropathy assessed by 10-gram monofilament With * Signs of abnormal loading as indicated by callus formation or hyperaemia Or * limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or * on renal replacement therapy Exclusion Criteria: * Patients currently prescribed with or in need of therapeutic footwear * Active or history of foot ulcer * Active Charcot's neuroarthropathy * History of major operation in the foot including amputation, * Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely * Unable to provide informed consent * Inability to follow the study instructions (as judged by the recruiting clinician).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure

Timeframe: Within 1 year of randomisation

Trial details

NCT IDNCT03958539

SponsorCountess of Chester NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-01

View on ClinicalTrials.gov More Diabetes Mellitus trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.