Dermastat® Study
Research type
Research Study
Full title
A study of medical device Dermastat® to assess its suitability as a new autonomic neuropathy testing device, in the diabetes clinical setting.
IRAS ID
279799
Contact name
Keeley Foley
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
It is important to know what type of equipment(s) can best predict harmful changes in the diabetic foot. This allows early intervention and prevention of skin damage which can lead to ulceration and amputation. This study will test the DermaStat® equipment which measures skin moisture by putting a probe on the skin (non-invasive and painless). If the moisture content is low, this implies glands controlled by nerves are not producing sweat and natural moisturisers.
DermaStat® is a new screening tool, so we want to compare its performance to existing methods for diagnosing neuropathy in adults with diabetes, as well as in a non-diabetic group. It is proposed that this be done in the diabetic out patient clinic, and added to the normal set of check-ups. The testing process is quick and will only happen once for each participant. The probe will be applied to 2 areas of the foot, which will take approximately 3-5 minutes.
We need to find out whether the new test works in people with diabetes and either no nerve damage, or various levels of existing nerve damage. Therefore, participants will be placed into one of 4 groups for people with diabetes and one non-diabetic control group. We will compare the results within these groups, but we will also compare the results to see if normal and abnormal readings are consistent with existing tests reflecting diabetic nerve damage.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0074
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion