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

King's College Hospital NHS Trust3 sites in 1 country105 target enrollmentJuly 2015

ConditionsDiabetic Foot

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: King's College Hospital NHS Trust
Enrollment: 105
Locations: 3
Primary Endpoint: Detection of hot spots on a foot thermal map image
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

King's College Hospital NHS Trust

Responsible Party

Sponsor

Eligibility Criteria

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