Prevention of Primary Foot Ulcers in High-risk Diabetes Patients

NCT ID: NCT03958539

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-02-12

Brief Summary

This is a primary prevention study which 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

Detailed Description

Once a patient with diabetes develops 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 and an average weekly care cost of £208 per person. 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. Scanners and software are likely to be offered free if this is scaled up. The investigators 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. 450 diabetes patients with high-risk feet would be recruited who would be prepared to wear the custom made 3D printed insoles on a regular basis (Intervention group). The control group will be formed of 450 diabetes patients with high-risk feet who will receive standard care.

Conditions

Diabetes Mellitus; Foot Ulcer, Diabetic; Primary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention arm

6 sites out of a total of 12 will act as the intervention sites. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to be provided with bespoke 3-D printed insoles.

Group Type: ACTIVE_COMPARATOR

3D printed insoles for normal footware

Intervention Type: DEVICE

Imprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole.

The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan.

Control

6 sites out of a total of 12 will act as the control sites providing standard care. 450 Patients with high risk of primary DFUs defined by peripheral sensory neuropathy and callus formation or critical limb ischaemia or on renal replacement therapy will be cluster randomised to standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3D printed insoles for normal footware

Imprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole.

The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of diabetes (type 1 or 2)
• Aged ≥18
• Peripheral sensory neuropathy assessed by 10-gram monofilament With
• Signs of abnormal loading as indicated by callus formation or hyperaemia Or
• limb ischaemia as evidenced by intermittent claudication /non-palpable pulses / history of vascular intervention Or
• on renal replacement therapy

Exclusion Criteria

• Patients currently prescribed with or in need of therapeutic footwear
• Active or history of foot ulcer
• Active Charcot's neuroarthropathy
• History of major operation in the foot including amputation,
• Local / systemic symptoms of infection, severe illness that would make 12 month survival unlikely
• Unable to provide informed consent
• Inability to follow the study instructions (as judged by the recruiting clinician).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liverpool

OTHER

Sponsor Role: collaborator

Staffordshire University

OTHER

Sponsor Role: collaborator

Countess of Chester NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Nair, FRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Countess of Chester Hospital NHS Trust, Chester, UK

Locations

Countess of Chester NHS Trust

Chester, Cheshire, United Kingdom

Countries

United Kingdom

Other Identifiers

265590

Identifier Type: OTHER

Identifier Source: secondary_id

265590

Identifier Type: -

Identifier Source: org_study_id