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

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01269502
Enrollment
41
Registered
2011-01-04
Start date
2009-06-30
Completion date
2013-10-31
Last updated
2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcer, Diabetic

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.

Interventions

DEVICETemp Touch Diabetica Solutions inc.

Daily measurement of skin temperature on feet for one year

Inspection of feet daily for one year

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Previous neuropathic diabetic foot ulcer

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Recurrency of diabetic foot ulcerOne year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026