Diabetic Foot
Conditions
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.
Interventions
DEVICEDFUPS
The DFUPS device is a two-camera instrument for capturing images of feet
Sponsors
Photometrix
National Physical Laboratory
University of South Wales
Freeman Health System
Pennine Acute Hospitals NHS Trust
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of hot spots on a foot thermal map image | 9 months |
Countries
United Kingdom
Outcome results
None listed