Diabetic Foot
Conditions
Keywords
Diabetic Foot, foot temperature, diabetic foot ulcer
Brief summary
The purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (DFUPS) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. It is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. These measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. It is hoped to find out whether the regular use of thermal images taken with the DFUPS device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.
Interventions
DEVICEDFUPS
The DFUPS device is a two-camera instrument for capturing images of feet.
Sponsors
Freeman Health System
Pennine Acute Hospitals NHS Trust
National Physical Laboratory
University of South Wales
Photometrix
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Has either type 1 or type 2 diabetes * Has intact feet as defined by the absence of a skin breakdown below the malleoli. * Has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold \> 25 volts on one OR both feet) * Has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months * Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both) * Has no history of peripheral arterial disease * Has footwear which in the opinion of the investigator is not likely to cause pressure damage * Must be able to provide meaningful written informed consent for the study
Exclusion criteria
* Is aged \<18 * Has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study. * Has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study * Has active foot ulceration and infection * Has active Charcot osteoarthropathy * Has established Charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study. * Has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study * Has an implantable electronic device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients developing a foot ulcer | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to ulceration | 12 months |
| Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L | 12 months |
Countries
United Kingdom
Outcome results
None listed