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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01269502
First received: January 3, 2011
Last updated: September 18, 2014
Last verified: September 2014
  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?

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Recurrency of diabetic foot ulcer [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: June 2009
Study Completion Date: October 2013
Primary Completion Date: October 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
Criteria

Inclusion Criteria:

  • Previous neuropathic diabetic foot ulcer

Exclusion Criteria:

  • Ankle/brachial index < 0.7. Osteomyelitis, active Charcot
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01269502

Locations
Norway
Oslo university Hospital Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
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: September 18, 2014
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Ulcer
Pathologic Processes
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014