Clinical trial NCT01269502: 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
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Previous neuropathic diabetic foot ulcer

Exclusion Criteria:

* Ankle/brachial index \< 0.7. Osteomyelitis, active Charcot

Primary outcomes:
measure: Recurrency of diabetic foot ulcer
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university Hospital Ulleval
Study officials:
affiliation: Oslo University Hospital Ulleval, Oslo, Norway
name: Bente K Kilhovd, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Ulleval, Oslo, Norway
name: Anita Skafjeld
role: STUDY_CHAIR
References:
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.