Prevention Of Foot Ulcers in high-risk diabetes patients (PROFOUND)
Research type
Research Study
Full title
Prevention Of primary Foot Ulcers in high-risk diabetes patients (PrOFoUnD): A cluster randomised trial of 3D printed Insoles Versus Standard Care
IRAS ID
265590
Contact name
Sunil Nair
Contact email
Sponsor organisation
Countess of Chester NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 28 days
Research summary
Once a patient with diabetes has a foot ulcer ~80% are likely to have a lower limb amputation in the future. Amputation carries a considerable burden of cost and impaired quality of life (QOL) and is associated with a 5-year mortality rate of 70%. Once a patient develops an ulcer they remain at high risk for life and are likely to suffer considerable morbidity, debilitation, reduced quality of life and numerous attendances with health care professionals including emergency hospital presentation. There are significant costs associated with the management of diabetes foot ulcers (DFU) which accounts for £1 billion of NHS funding. Both diabetes ulcers and amputation for the most part are preventable providing that patients have effective glycaemic control, regular foot assessments, care for their feet appropriately and wear appropriate footwear or orthotic wear to prevent ulceration.
The focus of this initiative is to utilise digital capability by 3D scanning systems in the community for the provision of highly cost-effective 3D printed soles for shoes which distribute the pressure on the feet whilst having the flexibility of being used in general footwear, thus improving compliance. The cost of these soles is very low at approximately £40 for two pairs. More complex orthotics cost on average £525 each. We are proposing to work closely with podiatrists in local foot protection services to assess a number of patients at high risk of foot ulcer and deliver a care bundle, which will include assessment, education around both foot care and promoting structured education and 3D sole provision.
The study aims to assess reduction in the rate of diabetic foot ulcers in patients with high-risk diabetic feet using 3D printed insoles compared to standard care. The secondary outcome measures will be improvement in standardised QOL measures.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0389
Date of REC Opinion
28 Aug 2019
REC opinion
Further Information Favourable Opinion