Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PROFOUND)

Prevention of Primary Foot Ulcers in High-risk Diabetes Patients (PrOFoUnD): a Cluster Randomised Trial of 3D Printed Insoles Versus Standard Care

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

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Primary Prevention; Foot Ulcer, Diabetic
• Intervention / Treatment: Device: 3D printed insoles for normal footware

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 Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Chester, Cheshire, United Kingdom, CH2 1UL
      • Countess of Chester NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Countess of Chester NHS Foundation Trust
• Collaborators: University of Liverpool; Staffordshire University
• Investigators: Principal Investigator: Sunil Nair, FRCP, PhD, Countess of Chester Hospital NHS Trust, Chester, UK

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 19, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetes Mellitus; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: 265590 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No