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Oxford University Hospitals NHS Foundation Trust

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Option-DM

Trial categories: Diabetes

Sponsoring organisation: University of Sheffield

Optimal Pathway for TreatIng Neuropathic Pain in Diabetes Mellitus

The number of people with diabetes is growing rapidly in the UK.

Unfortunately, diabetes causes nerve damage that in turn can cause painful symptoms in the feet, legs and hands. One quarter of all people with diabetes experience these symptoms, known as 'painful diabetic neuropathy'.

Currently, the recommended treatment in the UK is a choice of four medications; amitriptyline, duloxetine, pregabalin or gabapentin. If initial treatment with one of these drugs is not fully effective, it is recommended that one of the other medications is added in combination with the first.

Until now, these medications, and their combinations, have not been systematically compared against each other to see which is best. We want to find out which is the most effective initial treatment and then the best combination treatment for patients with painful diabetic neuropathy. We will do this by comparing three different treatment pathways using amitriptyline, duloxetine and pregabalin, and their combinations.

We are looking for people over 18 years of age who have painful diabetic neuropathy.

Taking part in the study will involve trying three different treatment pathways using the medications amitriptyline, duloxetine and pregabalin in different combinations. You would be in the study for approximately one year. Once you have completed the three pathways you will have completed the study.

These are medications that are already commonly used to treat this condition.

The study visits would involve gathering clinical information, body measurements, questionnaires, blood tests, and neuropathy assessment.

If you have any questions or would like an information sheet please contact the study team.

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