CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Education and Thermometer Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03506776
NCT03506776N/ACompleted

Foot Intervention Study Utilizing Commercially Available Infrared Thermometers With Individuals With Diabetes Using a Mixed Methods Approach

Memorial University of Newfoundland·interventional·Posted Apr 24, 2018·Updated Apr 29, 2020

In Brief

A clinical study evaluating Education and Thermometer Group and Education Only Group for Diabetic Foot. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Foot self-management is important in preventing diabetic foot ulcers. However, even when individuals care for their feet, the signs of inflammation are often missed. A tool that will identify inflammation, a sign of initial tissue damage, may be needed. Previous research has shown that foot temperature self-monitoring reduced ulcer incidence by providing a warning sign of inflammation. However, these studies used an expensive medical thermometer. The objectives for this mixed-methods study are: (1) to determine if a foot health intervention that utilizes an inexpensive commercially-available infrared thermometer (CAIT) improves foot outcomes for individuals with diabetes; (2) to identify factors impacting foot self-management; (3) and to explore the participants', family and support persons', and healthcare providers' experiences with foot self-management and the intervention. This study will have three phases: Phase 1, patients, family and support person, and healthcare providers will share their insights regarding foot self-management to inform the intervention; Phase 2, a six-month RCT will assess the effectiveness of a CAIT; Phase 3, interviews will be conducted with participants, family and support persons, and health providers to explore their experiences with the intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot
CountriesCanada

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 24, 2018
Enrollment StartAug 21, 2017
Primary CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.2 years ago

Interventions

Education and Thermometer Groupdevice

The education will be provided in video format utilizing the Canadian Association of Wound Care (CAWC) diabetic foot management YouTube video and one-on-one teaching. Participants will be provided with an inspection mirror with an extendable handle to assist with visualizing the bottom of the feet and a pedometer to measure daily activity. One-on-one teaching with the thermometer will be provided. Participants will be given a handout for reference on using the thermometer. The foot model will be marked with a zigzag pattern on the plantar surface to illustrate the path that should be used when measuring temperature. The support person will be included in the teaching if he/she will be assisting the participant to obtain temperature readings.

Education Only Groupother

The education will be provided in video format utilizing the Canadian Association of Wound Care (CAWC) diabetic foot management YouTube video and one-on-one teaching. Participants will be provided with an inspection mirror with an extendable handle to assist with visualizing the bottom of the feet and a pedometer to measure daily activity.