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Search / Trial NCT06739135

Driving with Neuropathy

Launched by MANCHESTER METROPOLITAN UNIVERSITY · Dec 16, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Randomised Controlled Trial Diabetic Peripheral Neuropathy Driving Driving With Neuropathy

ClinConnect Summary

The "Driving with Neuropathy" trial is studying how a special visual feedback system can help drivers with diabetic peripheral neuropathy (DPN) use the accelerator pedal more safely. The researchers want to find out if this feedback can reduce the amount of time drivers push the pedal down too far, which can be a sign of unsafe driving. Participants will be tested in a driving simulator to see how they drive, and those who push the pedal down more than a certain limit will be randomly assigned to either receive the feedback intervention or not. The study will also include drivers with diabetes who do not have neuropathy to compare their driving behavior.

To be eligible for the study, participants need to have a valid UK driving license and have been driving for at least five years. They should drive a car at least once a week and be diagnosed with type 2 diabetes, either with or without diabetic peripheral neuropathy. During the trial, those in the feedback group will participate in six sessions spaced out over several months, while the control group will have their driving assessed at the same points without receiving the feedback. This trial is important as it aims to improve driving safety for people with diabetes and neuropathy.

Gender

ALL

Eligibility criteria

  • 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).

About Manchester Metropolitan University

Manchester Metropolitan University is a leading institution in the UK, renowned for its commitment to advancing research and innovation across various disciplines, including health and clinical sciences. The university actively engages in clinical trials aimed at improving patient outcomes and enhancing healthcare practices. With a focus on collaboration and interdisciplinary approaches, Manchester Metropolitan University leverages its diverse expertise and state-of-the-art facilities to conduct rigorous research that addresses pressing health challenges. Its dedication to ethical standards and community involvement ensures that clinical studies not only contribute to scientific knowledge but also prioritize participant welfare and societal benefit.

Locations

Manchester, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Dilwyn Marple-Horvat, DPhil

Principal Investigator

Manchester Metropolitan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported