Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Device: DFUPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFUPS (visual and thermal images)<br>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. | Device: DFUPS<br>* The DFUPS device is a two-camera instrument for capturing images of feet.<br>|
| Placebo Comparator: DFUPS ( visual images)<br>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. | Device: DFUPS<br>* The DFUPS device is a two-camera instrument for capturing images of feet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients developing a foot ulcer |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot, foot temperature, diabetic foot ulcer