Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01269502
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: "Temp Touch" Diabetica Solutions inc. Other: Inspection Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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?
Study Start Date : June 2009
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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
Other: Inspection
Inspection of feet daily for one year

Primary Outcome Measures :
  1. Recurrency of diabetic foot ulcer [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previous neuropathic diabetic foot ulcer

Exclusion Criteria:

  • Ankle/brachial index < 0.7. Osteomyelitis, active Charcot

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01269502

Oslo university Hospital Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Bente K Kilhovd, Md, PhD Oslo University Hospital Ulleval, Oslo, Norway
Study Chair: Anita Skafjeld Oslo University Hospital, Ulleval, Oslo, Norway

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oslo University Hospital Identifier: NCT01269502     History of Changes
Other Study ID Numbers: 6.2009.60
20 ( Other Grant/Funding Number: Sophies Minde Ortopedi AS )
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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