Prevention of Secondary Foot Ulcers in Patients With Diabetes Using

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01269502
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Completed
Phase	N/A
Start date	June 2009
Completion date	October 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03942081` - Diabetic Foot Ulcer Imaging- Study 2	N/A
Not yet recruiting	`NCT06023810` - The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers	N/A
Recruiting	`NCT02838784` - Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers	N/A
Terminated	`NCT01729286` - Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix	N/A
Completed	`NCT01699100` - Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design	N/A
Completed	`NCT05908968` - Assessing the Effects of ELO Water on Diabetic Foot Ulcers	N/A
Recruiting	`NCT05586542` - Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers	Phase 1
Completed	`NCT02581488` - Use of Santyl in Diabetic Foot Ulcers	Phase 4
Completed	`NCT02334241` - The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)	N/A
Completed	`NCT01956162` - Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients	N/A
Completed	`NCT00796744` - Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers	Phase 2
Recruiting	`NCT04210089` - Total Contact Soft Cast in Diabetic Foot Ulcers	N/A
Completed	`NCT02647346` - In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers	N/A
Completed	`NCT01480362` - Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds	N/A
Terminated	`NCT01013792` - A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers	N/A
Completed	`NCT01580917` - Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study	N/A
Completed	`NCT02427802` - Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers	Phase 3
Completed	`NCT02451722` - Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear	N/A
Terminated	`NCT01858545` - A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers	N/A
Completed	`NCT00516958` - Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms