Supply chain evaluation for foot orthotic provision in the NHS
Research type
Research Study
Full title
Randomised controlled trial comparing the efficacy of foot orthoses produced by traditional and digital design processes, to reduce pressure and assess the impact on clinical practice.
IRAS ID
186563
Contact name
Christopher Nester
Contact email
Sponsor organisation
University of Salford
ISRCTN Number
ISRCTN10978940
Duration of Study in the UK
1 years, 1 months, 16 days
Research summary
This randomised controlled study will compare two ways of designing and producing foot orthotics (insoles) for the management of foot problems in diabetes.
We are comparing traditional plaster of paris casting of feet and heat moulding of orthotic insoles, to digital scanning of the foot and computerised production of orthotic insoles . These methods were chosen as they are currently used in the NHS but any differences in their effect are not fully understood.
We will compare the orthotic insoles produced by each method in terms of changes in the pressures under the foot while walking. Reducing 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 the orthotics insoles and inform NHS policies for the future.
The 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.
After receiving the orthotic insoles participants will be asked to take part in monthly telephone calls to talk about their use of the orthotic insoles and about the foot care services they may have used. Participants will also be asked to attend two follow up appointments, at 3 and 6months after receiving the orthotic insoles, to help us to understand if their original performance is maintained.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0392
Date of REC Opinion
27 Oct 2015
REC opinion
Further Information Favourable Opinion