Skip to main content
OpenTrials
Completed

NCT Number: NCT01269502

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Foot Ulcer, Diabetic Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university Hospital Ulleval

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous neuropathic diabetic foot ulcer

Exclusion criteria

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

Treatment and study plan

"Temp Touch" Diabetica Solutions inc.

Device

Daily measurement of skin temperature on feet for one year

Inspection

Other

Inspection of feet daily for one year

Primary outcomes

  1. Recurrency of diabetic foot ulcer

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study 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?

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2011
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.