Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
|ClinicalTrials.gov Identifier: NCT01269502|
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : September 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer, Diabetic||Device: "Temp Touch" Diabetica Solutions inc. Other: Inspection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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?|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Skin temperature measurement
Regular measurement of skin temperature on feet for one year
Device: "Temp Touch" Diabetica Solutions inc.
Daily measurement of skin temperature on feet for one year
Active Comparator: Active control
Daily inspection of feet for one year
Inspection of feet daily for one year
- Recurrency of diabetic foot ulcer [ Time Frame: One year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269502
|Oslo university Hospital Ulleval|
|Oslo, Norway, 0407|
|Principal Investigator:||Bente K Kilhovd, Md, PhD||Oslo University Hospital Ulleval, Oslo, Norway|
|Study Chair:||Anita Skafjeld||Oslo University Hospital, Ulleval, Oslo, Norway|