Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
Primary Purpose
Foot Ulcer, Diabetic
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
"Temp Touch" Diabetica Solutions inc.
Inspection
Sponsored by
About this trial
This is an interventional prevention trial for Foot Ulcer, Diabetic
Eligibility Criteria
Inclusion Criteria:
- Previous neuropathic diabetic foot ulcer
Exclusion Criteria:
- Ankle/brachial index < 0.7. Osteomyelitis, active Charcot
Sites / Locations
- Oslo university Hospital Ulleval
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Skin temperature measurement
Active control
Arm Description
Regular measurement of skin temperature on feet for one year
Daily inspection of feet for one year
Outcomes
Primary Outcome Measures
Recurrency of diabetic foot ulcer
Secondary Outcome Measures
Full Information
NCT ID
NCT01269502
First Posted
January 3, 2011
Last Updated
September 18, 2014
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01269502
Brief Title
Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin temperature measurement
Arm Type
Experimental
Arm Description
Regular measurement of skin temperature on feet for one year
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Daily inspection of feet for one year
Intervention Type
Device
Intervention Name(s)
"Temp Touch" Diabetica Solutions inc.
Intervention Description
Daily measurement of skin temperature on feet for one year
Intervention Type
Other
Intervention Name(s)
Inspection
Intervention Description
Inspection of feet daily for one year
Primary Outcome Measure Information:
Title
Recurrency of diabetic foot ulcer
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous neuropathic diabetic foot ulcer
Exclusion Criteria:
Ankle/brachial index < 0.7. Osteomyelitis, active Charcot
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente K Kilhovd, Md, PhD
Organizational Affiliation
Oslo University Hospital Ulleval, Oslo, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anita Skafjeld
Organizational Affiliation
Oslo University Hospital, Ulleval, Oslo, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo university Hospital Ulleval
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26452544
Citation
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.
Results Reference
derived
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Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
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