Foot Intervention Study Utilizing Commercially Available Infrared Thermometers With Individuals With Diabetes

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.

Conditions

• Diabetic Foot

Interventions

DEVICE

Education and Thermometer Group

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.

OTHER

Education Only Group

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.

Sponsors & Collaborators

• Health Care Foundation, NL, Canada

  collaborator UNKNOWN

• Association of Registered Nurses of Newfoundland and Labrador

  collaborator UNKNOWN

• NL-SUPPORT, NL, Canada

  collaborator UNKNOWN

• Memorial University of Newfoundland

  lead OTHER

Principal Investigators

• Kathleen Stevens, PhD(c) · Memorial University of Newfoundland and Labrador

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-21

Primary Completion

2019-10-30

Completion

2019-10-30

Countries

• Canada

Study Locations