Diabetic Foot Ulcer Prevention System

To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

King's College Hospital, London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 18 years or older
Has no history of diabetes
Has no previous history of foot ulceration
Has no previous history of foot surgery
Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
Has no history of peripheral neuropathy
Has no history of peripheral arterial disease
Must be able to provide meaningful written informed consent for the study

Exclusion criteria

Has active foot ulceration and infection
Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
Has an implantable electronic device
Is aged <18

Treatment and study plan

DFUPS

Device

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

Primary outcomes

Detection of hot spots on a foot thermal map image

Time frame: 9 months

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

Freeman Health System
National Institute for Health Research, United Kingdom
National Physical Laboratory
Pennine Acute Hospitals NHS Trust
Photometrix
University of South Wales

Registry information

Official study title

An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers

Acronym: DFUPS

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Dec 17, 2014
Registry last updated: Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed