Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Foot Ulcer, Diabetic |
Device: "Temp Touch" Diabetica Solutions inc. Other: Inspection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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? |
- Recurrency of diabetic foot ulcer [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: "Temp Touch" Diabetica Solutions inc.
|
|
Active Comparator: Active control
Daily inspection of feet for one year
|
Other: Inspection
Inspection of feet daily for one year
Other Name: Inspection
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous neuropathic diabetic foot ulcer
Exclusion Criteria:
- Ankle/brachial index < 0.7. Osteomyelitis, active Charcot
Contacts and Locations| Norway | |
| 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 |
More Information
No publications provided
| Responsible Party: | Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01269502 History of Changes |
| Other Study ID Numbers: | 6.2009.60, 20 |
| Study First Received: | January 3, 2011 |
| Last Updated: | April 16, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Additional relevant MeSH terms:
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on May 22, 2013