Prevention of Primary Foot Ulcers in High-risk Diabetes Patients

Not Applicable

Terminated

• Conditions: Diabetes Mellitus; Primary Prevention; Foot Ulcer, Diabetic
• Interventions: Device: 3D printed insoles for normal footware

• Registration Number: NCT03958539
• Lead Sponsor: Countess of Chester NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-19
• Study First Posted: 2019-05-22
• Study Start: 2019-09-01
• Status Verified: 2021-01
• Primary Completion: 2023-04-01
• Study Completion: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 900

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	3D printed insoles for normal footware	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.

Primary Outcome Measures

Name	Time	Method
The incidence of new ulcer in patients with high-risk diabetic feet is our primary outcome measure	Within 1 year of randomisation	Ulcer is defined as any new break in the skin of the feet

Secondary Outcome Measures

Name	Time	Method
To compare patient satisfaction at baseline 26, and 52 weeks post randomisation	Within 1 year of randomisation	standardised questionnaires
To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation	Within 1 year of randomisation	standardised questionnaires
Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation	Within 1 year of randomisation	AE event recording
New callus formation	Within 1 year of randomisation	Clinical examination by podiatrists
To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation	Within 1 year of randomisation	standardised questionnaires
Need for debridement of callus	Within 1 year of randomisation	Clinical examination by podiatrists

Trial Locations

Locations (1)

Countess of Chester NHS Trust; 🇬🇧 Chester, Cheshire, United Kingdom