Diabetic Foot Ulcer Prevention System
Phase 1
Completed
- Conditions
- Diabetic Foot
- Interventions
- Device: DFUPS
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study in healthy volunteers DFUPS Skin foot temperature measurement by DFUPS device
- Primary Outcome Measures
Name Time Method Detection of hot spots on a foot thermal map image 9 months
- Secondary Outcome Measures
Name Time Method
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