Institution
King’s College London
Name of lead investigator
Dr David Bennett
Research funded by
Wellcome Trust
Who to contact
Dr Juan Ramirez, Clinical Research Assistant
Tel: 07902 114851
Email: juan.ramirez@ndcn.ox.ac.uk
Recruiting until
June 2015
Total number of participants needed
400
Who can and cannot take part?
Inclusion criteria
Participants should be over 18 years of age and have diabetes and neuropathy. Participants should also be physically able to take part in the study and be able to speak fluent English.
Exclusion criteria
Participants must not be pregnant or have a severe psychological or psychiatric disorder.
About the research
What is the research about?
Pain reduces quality of life, and is one of the most common complications of diabetes-related neuropathy. Little is known about why some patients with neuropathy develop pain, when others do not. Using sophisticated techniques to measure the extent of a person’s neuropathy, this study aims to identify the factors associated with the development and varying intensity of pain and begin to determine the risk factors involved.
How will the research benefit people with diabetes?
The researchers hope to identify the underlying causes and risk factors associated with the development of pain related to neuropathy. In future, this knowledge will assist the development of new therapeutic approaches for painful neuropathy, improving the lives of many people who suffer this complication as a result of diabetes.
What will taking part in the research involve for participants?
Taking part in the study will involve visiting a study site (either at the Guy’s hospital campus of King’s College London) or Chelsea and Westminster Hospital at a time convenient to the participant. The study visit will last for three hours and can be undertaken either during one appointment or, if the participant prefers, two appointments.
Participants will answer a number of questionnaires about symptoms such as numbness and pain and will undergo a clinical examination and tests of sensation (such as having a warm probe touched against the participant’s skin and being asked what they can feel). The study will also involve an optional blood test and skin biopsy.
What are the risks involved in taking part?
With the collection of a small piece of skin, there is a virtually non-existent risk of discomfort, infection, scaring, or bleeding. The researchers have chosen to use the smallest skin punch biopsy possible (3mm) to minimise these risks. Other than that, there are no associated risks.
Is there any compensation for taking part?
The researchers will reimburse the travel costs of participants who take part in the study.