Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.

Study Overview
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Brief Summary
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A randomised controlled pilot study on the feasibility of introducing a skin temperature device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have had a foot ulcer in Norway.

Detailed Description
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Diabetes mellitus is linked to late complications from kidneys, eyes, nerves, feet, and an increased risk of cardiovascular disease. Approximately 170 000 people in Norway suffer from diabetes, and diabetic foot disease is one of the most common complications. It is estimated that between 400 and 500 amputations are performed yearly in Norway, and most of the amputations are due to non-healing diabetic foot ulcers. Efficient prevention in high-risk individuals includes follow-up in specialist foot clinics including training in self-care, adaptation of preventive footwear and insoles. A randomised trial testing the use of skin temperature measurement in addition to routine foot care for preventing new foot ulcers showing a highly significant reduction in recurrent foot ulcers in the temperature measuring group, has previously been performed in USA (Lavery et al. Diabetes Care 2007;30:14). This study is planned as an open, randomised pilot study of minimum 40 patients testing the feasibility of implementing the use of skin temperature measurement for prevention of recurrent diabetic foot ulcers in a specialist clinical setting in Norway. If this is the case, we are planning a larger study to examine if these measurements can contribute to reducing the number of recurrent ulcers in clinical practice in Norway. We are in addition using a cognitive motivational method to examine if this model can increase the use of the temperature measuring device.

Official Title
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Prevention of Secondary Foot Ulcers in Patients With Diabetes. Will People With Diabetes Who Have Had a Foot Ulcer be Able to Prevent Secondary Ulcers by Systematically Measuring Their Skin Temperature?

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: Temp Touch Diabetica Solutions inc.
* Other: Inspection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous neuropathic diabetic foot ulcer Exclusion Criteria: Ankle/brachial index < 0.7. Osteomyelitis, active Charcot

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin temperature measurement<br>Regular measurement of skin temperature on feet for one year | Device: Temp Touch Diabetica Solutions inc.<br>* Daily measurement of skin temperature on feet for one year<br>|
| Active Comparator: Active control<br>Daily inspection of feet for one year | Other: Inspection<br>* Inspection of feet daily for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrency of diabetic foot ulcer |  | One year |