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Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

NCT02579070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-09-17

No results posted yet for this study

Summary

The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.

Conditions

  • Diabetic Foot

Interventions

DEVICE

DFUPS

The DFUPS device is a two-camera instrument for capturing images of feet.

Sponsors & Collaborators

  • Freeman Health System

    collaborator OTHER

  • Pennine Acute Hospitals NHS Trust

    collaborator OTHER

  • National Physical Laboratory

    collaborator OTHER

  • University of South Wales

    collaborator OTHER

  • Photometrix

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Michael Edmonds, MD, FRCP · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-08
Primary Completion
2017-09-27
Completion
2017-09-27

Countries

  • United Kingdom

Study Locations

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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 NCT02579070 on ClinicalTrials.gov