Insole to Ease Pressure (INSTEP)
Research type
Research Study
Full title
A multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.
IRAS ID
224903
Contact name
Richard Collings
Contact email
Sponsor organisation
University of Plymouth
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
INSTEP - INSoles To Ease Pressure . A multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy. \n\nOne of the common problems associated with diabetes is the development of foot ulcers. These are frequently associated with high pressure areas and loss of feeling in the feet.\n\nInsoles and specialist shoes are often provided to move the pressure from the high impact areas to other parts of the foot to try and either heal the ulcer or reduce the risk of ulcers occurring. Unfortunately there are frequent delays in providing the insoles and shoes and no way of testing how efficient they are in moving the pressure around the foot. \n\nTherefore the National Institute of Health Research have funded this study to compare 2 groups of 38 people with diabetes and sensory neuropathy that have been categorised as high risk of developing a foot ulcer from Torbay, Exeter and the Solent areas. One group will be given special insoles made using new technology (a sensor that fits inside the patient’s shoe measuring the walking pressures under the foot) and the other will be given plain cushioned insoles. We will determine whether there is any difference in reducing the harmful pressure points and stopping ulcers forming between the groups over a 12 month period. We also want to interview 12 of the participants and the three clinicians taking part about their experiences of being in the trial.\n\nOnce we have collected all of the data we intend to run a large scale trial over many areas around the country to test this new idea. Ultimately we hope to reduce the risk of people with diabetes developing foot ulcers. \n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0169
Date of REC Opinion
18 Sep 2017
REC opinion
Further Information Favourable Opinion