We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Erica
Wallis
erica.wallis1@nhs.net
Sharon
Caunt
sharon.caunt@nhs.net
Gordon
Sloan
gordon.sloan@sheffield.ac.uk
Sharon
Caunt
sharon.caunt@nhs.net
Erica
Wallis
erica.wallis1@nhs.net
Eva
Zincone
eva.zincone@nhs.net
Polyneuropathies and other disorders of the peripheral nervous systemDiabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This study will examine new methods of assessing pain in people with Diabetes using objective brain scan techniques. We will recruit 50 participants to the study, 24 with Diabetes and Nerve Pain in the Feet (Painful-DPN) and 26 people without Painful-DPN (13 with Diabetes and 13 without Diabetes and without other serious health conditions). People with Diabetes will be recruited from Sheffield Teaching Hospitals outpatient clinics and people without diabetes from local advertisement.
All participants will be invited to a first study visit which will last at most 120 minutes. They will be asked about their medical history; have a physical examination; assessments of nerve function; and complete questionnaires to assess mood, cognition, quality of life. At their second visit, all participants will undergo a brain scan, a certain type of Magnetic Resonance Imaging scan (31-Phosphorus Magnetic Resonance Spectroscopy). Participants with Painful-DPN will undergo this scan whilst taking their pain medications. This visit will take around 60-minutes, with approximately 30 minutes of scan time. This will conclude the involvement for participants without Painful-DPN.
Participants with Painful-DPN will undergo a second scan (at visit 3) after discontinuing their treatments for nerve pain in their feet. These medications will be reduced and then stopped entirely, in most people this will be, for 36-48 hours. The second scan visit will be the same as the first. After participants have undergone this scan their treatments will be re-introduced.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cross-sectional;
You can take part if:
You may not be able to take part if:
Insufficient command of the English language (as the questionnaires are validated for use in English) or mental capacity to provide informed consent. Moderate to severe pain from causes other than DPN. Nondiabetic neuropathies (e.g., thyroid disease; vitamin B12 or folate deficiencies; drug-induced or toxic neuropathy; inflammatory, autoimmune, or genetic neuropathy). Other diabetic neuropathies (e.g., lumbosacral plexopathy, mononeuropathies). Contraindications for MRI (claustrophobia, or irremovable ferromagnetic metalwork on their person such as a pacemaker). Potential confounding factors for neuroimaging (neurological disorder [e.g. epilepsy/stroke], antidepressant prescription). Excessive alcohol usage (sustained use of > 14 units/week). Major lower limb amputation. Severe recurrent hypoglycaemia. Unwillingness to discontinue analgesia in the Painful-DPN group for the required period of time.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Gordon
Sloan
gordon.sloan@sheffield.ac.uk
Sharon
Caunt
sharon.caunt@nhs.net
Eva
Zincone
eva.zincone@nhs.net
Erica
Wallis
erica.wallis1@nhs.net
Sharon
Caunt
sharon.caunt@nhs.net
Erica
Wallis
erica.wallis1@nhs.net
The study is sponsored by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST and funded by DIABETES CARE TRUST (ABCD) LIMITED .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 56566
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
