Efficacy and Safety of Diabetic Foot Ulcer Prevention System (DFUPS) - a Single Blind Randomised Clinical Trial in Diabetic Foot Patients at High Risk of Foot Ulceration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 6
- Primary Endpoint
- Percentage of patients developing a foot ulcer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
DFUPS (visual and thermal images)
Visual and thermal imaging with DFUPS and standard foot care. The study investigator will have access to the thermal and visual images captured with DFUPS.
Intervention: DFUPS (Device)
DFUPS ( visual images)
Visual and blinded thermal imaging with DFUPS and standard foot care. The study investigator will have access only to the visual images and will be blinded to the thermal images which will be captured at each visit but accessed only at the end of the study.
Intervention: DFUPS (Device)
Outcomes
Primary Outcomes
Percentage of patients developing a foot ulcer
Time Frame: 12 months
Secondary Outcomes
- Rate of change of score in quality of life from baseline and up to the final visit using the EQ-5D-5L(12 months)
- Time to ulceration(12 months)