Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
NCT ID: NCT01269502
Last Updated: 2014-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2009-06-30
2013-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Skin temperature measurement
Regular measurement of skin temperature on feet for one year
"Temp Touch" Diabetica Solutions inc.
Daily measurement of skin temperature on feet for one year
Active control
Daily inspection of feet for one year
Inspection
Inspection of feet daily for one year
Interventions
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"Temp Touch" Diabetica Solutions inc.
Daily measurement of skin temperature on feet for one year
Inspection
Inspection of feet daily for one year
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Principal Investigators
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Bente K Kilhovd, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital Ulleval, Oslo, Norway
Anita Skafjeld
Role: STUDY_CHAIR
Oslo University Hospital, Ulleval, Oslo, Norway
Locations
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Oslo university Hospital Ulleval
Oslo, Oslo County, Norway
Countries
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References
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Skafjeld A, Iversen MM, Holme I, Ribu L, Hvaal K, Kilhovd BK. A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial. BMC Endocr Disord. 2015 Oct 9;15:55. doi: 10.1186/s12902-015-0054-x.
Other Identifiers
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20
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
6.2009.60
Identifier Type: -
Identifier Source: org_study_id
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