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Clinical Trials/NCT01269502
NCT01269502
Completed
Not Applicable

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?

Oslo University Hospital1 site in 1 country41 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foot Ulcer, Diabetic
Sponsor
Oslo University Hospital
Enrollment
41
Locations
1
Primary Endpoint
Recurrency of diabetic foot ulcer
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Previous neuropathic diabetic foot ulcer

Exclusion Criteria

  • Ankle/brachial index \< 0.
  • Osteomyelitis, active Charcot

Outcomes

Primary Outcomes

Recurrency of diabetic foot ulcer

Time Frame: One year

Study Sites (1)

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