Diabetic Foot Ulcer Prevention System

Phase 1

Completed

• Conditions: Diabetic Foot

• Registration Number: NCT02317835
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-17
• Study Start: 2015-07
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-08
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection of hot spots on a foot thermal map image	9 months

Trial Locations

Locations (3)

King's College Hospital; 🇬🇧 London, United Kingdom

The Pennine Acute Hospitals NHS Trust; 🇬🇧 Manchester, United Kingdom

The Newcastle upon Tyne Hospitals; 🇬🇧 Newcastle upon Tyne, United Kingdom