Prevention of Primary Foot Ulcers in High-risk Diabetes Patients

NCT03958539 | Terminated DMC

• 1 other identifier: 265590
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus; Foot Ulcer, Diabetic; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To compare patient satisfaction at baseline 26, and 52 weeks post randomisation

  Within 1 year of randomisation

• To evaluate quality of life using NeuroQoL at baseline, 26, and 52 weeks post randomisation

  Within 1 year of randomisation

• Incidence of adverse events relating in the 3D insole group over 52 weeks post randomisation

  Within 1 year of randomisation

• New callus formation

  Within 1 year of randomisation

• To evaluate quality of life using EQ-5D-3L at baseline, 26, and 52 weeks post randomisation

  Within 1 year of randomisation

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

3D printed insoles for normal footware 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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Countess of Chester NHS Foundation Trust: lead
• University of Liverpool: collaborator
• Staffordshire University: collaborator

Study Sites (1)

Countess of Chester NHS Trust

Chester, Cheshire, CH2 1UL, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Officials

• Sunil Nair, FRCP, PhD

  Countess of Chester Hospital NHS Trust, Chester, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As this study involves a complex intervention in the form of a pathway, we chose a cluster randomisation design to mitigate the risk of contamination across the groups. The podiatry units will find it much easier to follow one pathway for all participants in their sites. We also reduce the cost by halving the number of foot scanners required to be purchased (and the staff training required) for the study by using cluster randomisation.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 22, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2023
• Study Completion: February 12, 2025
• Last Updated: February 14, 2025

Record last verified: 2021-01

Locations

GB (1)