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Prevention of Primary Foot Ulcers in High-risk Diabetes Patients

NCT03958539 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-02-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • Staffordshire University

    collaborator OTHER

  • Countess of Chester NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sunil Nair, FRCP, PhD · Countess of Chester Hospital NHS Trust, Chester, UK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-04-01
Completion
2025-02-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03958539 on ClinicalTrials.gov