Improving driving safety for patients with diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This proof-of-concept randomized controlled trial investigates the effectiveness of a visual feedback intervention aimed at improving accelerator pedal use in drivers with diabetic peripheral neuropathy (DPN). Participants will undergo a baseline driving assessment in a simulator, after which those who exceed a specific accelerator pedal threshold will be randomly assigned to either an intervention group receiving visual feedback or a control group with minimal intervention. The study will assess changes in driving behavior over six sessions spaced a month apart, focusing on reducing the percentage of time the accelerator pedal is pushed down beyond a critical angle. The primary goal is to enhance driving safety for individuals with DPN.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to understand English and all of the study requirements, including ability to provide informed consent
* Current full UK driving licence held, and for a minimum of 5 years (experienced drivers)
* Drives a car at least once per week on average (current drivers)
* Diagnosed with type 2 diabetes and diabetic peripheral neuropathy
* Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy)

Exclusion Criteria:

* Active foot ulcer on either foot
* Lower limb amputation involving more than two toes on the right foot
* Dementia
* Current participation in another research study that would compromise safety, or scientific integrity of either study (for example, a pharmaceutical trial that may affect ability to drive safely).

Where it's running

• Manchester Metropolitan University
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Dilwyn Marple-Horvat, DPhil — Manchester Metropolitan University
• Study coordinator: Maaike Esselaar, PhD
• Email: m.esselaar@mmu.ac.uk
• Phone: +44 787 310 9658

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.