Additive Manufacture in Orthotics (AMinO)
Research type
Research Study
Full title
Efficacy of additive manufactured orthotic insoles for the reduction of forefoot plantar pressure in the diabetic foot
IRAS ID
205108
Contact name
Christopher Nester
Contact email
Sponsor organisation
University of Salford
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 28 days
Research summary
The study will be a two phase trial to assess the performance of the additive manufactured orthotic insoles in terms of pressure reduction compared to milled and handmade orthotics currently in use within the NHS. \n\nReducing pressure under the ball of the foot is strongly linked to a reduced risk of foot ulceration. We will also evaluate the impact of the orthotic insoles on foot health, mobility and the use of other NHS services. This data will be used to assess any health and economic benefit of orthotics insoles and inform NHS policies for the future.\n\nThe study will be open to individuals who suffer from diabetes but have not had an active foot ulcer in the past and are current users of the orthotics service at the East Lancashire Hospitals NHS Trust. The study will be conducted within the orthotics clinic at the Royal Blackburn hospital and participants will receive the orthotic insoles to take home and wear alongside their normally provided orthotic footwear.\n\nIn phase one 10 different orthotic insoles produced according to a specific prescription provided by an orthotist will tested at the Royal Blackburn hospital. Additive manufactured orthotic insoles will be compared to handmade moulded and milled orthotic insoles to assess the immediate effect of pressure reduction. \n\nFollowing this in phase 2 participants will receive an additive manufactured orthotic insole to wear over a 6 month period. Data collected will be compared to historical controls collected in an ongoing study using handmade orthotic insoles and digitally designed milled orthotic insoles. This protocol allows for the demonstration of equivalent device performance at baseline, 3 month and 6 months of use.\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0386
Date of REC Opinion
15 Jun 2016
REC opinion
Further Information Favourable Opinion