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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506776
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Health Care Foundation, NL, Canada
Association of Registered Nurses of Newfoundland and Labrador
NL-SUPPORT, NL, Canada
Information provided by (Responsible Party):
Kathleen Stevens, Memorial University of Newfoundland

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Device: Education and Thermometer Group Other: Education Only Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Foot Intervention Study Utilizing Commercially Available Infrared Thermometers With Individuals With Diabetes Using a Mixed Methods Approach
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Education Only Group
The education only group will receive foot self-management education.
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.

Experimental: Education and Thermometer Group
The intervention group will receive foot self-management education. Additionally, the intervention group will receive a Commercially Available Infrared Thermometer (CAIT). Education on use of the CAIT will be provided through demonstration using a foot model and CAIT.
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 Name: Infrared Thermometer




Primary Outcome Measures :
  1. change from baseline foot assessment as evidenced by a diabetic foot ulcer [ Time Frame: time to ulceration up to 24 weeks ]
    Screening for the high risk diabetic foot: A 60 second foot tool (2012) Sibbald


Secondary Outcome Measures :
  1. change from baseline foot assessment as evidenced by presence or absence of skin breakdown [ Time Frame: Completed by participant daily up to 24 weeks ]
    Foot Assessment Log completed by participant

  2. change from baseline foot assessment evidenced by presence or absence of redness [ Time Frame: Completed by participant daily up to 24 weeks ]
    Foot Assessment Log completed by participant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Healthcare Providers (Phase 1 and 3)

Inclusion criteria are:

  1. Provide care to diabetic individuals (Phase 1 only)
  2. Work in one of the following areas: Eastern Health Diabetes Centre, Wound Care Clinic, and Community Health St. John's Region; Family Physician Clinics; Nurse Practitioner Clinics; and Podiatry Clinics (Phase 1 only)
  3. Were consulted by participants during the intervention (Phase 3 only)

Patients (All Phases)

Inclusion criteria are:

  1. Able to read and speak English
  2. Reachable by telephone
  3. 18 years of age and older
  4. History fits with International Diabetic Foot Risk Classification System category 2 (decreased sensation and blood supply or foot deformity) or category 3 (previous ulcer or amputation) (Peters, 2005).

Inclusion criteria (Phase 2)

  1. Callus and/or
  2. Deformity and/or
  3. One areas of loss of sensation as determined by assessment with Semmes Weinstein Monofilament

Exclusion criteria are:

  1. Ulcer
  2. Amputation sites not healed
  3. Foot infections
  4. Charcot arthropathy
  5. Pregnancy and/or breastfeeding (pregnancy causes changes to feet; these women may find the demands of the study too great in consideration of the life changes they are experiencing)
  6. Major health conditions
  7. Inability to read the thermometer and no support person available to assist the participant with temperature reading and documentation on a daily basis
  8. Severe peripheral vascular disease (PVD), as evidenced by non-palpable pulses or an ankle brachial index of < 0.7 on either extremity (Armstrong et al., 2007)
  9. Unable to walk without assistance.

Family/Support Persons (Phase 1 and 3)

Inclusion criteria are:

  1. 18 years of age and older (Phase 1 and 3).
  2. Able to read and speak English (Phase 1 and 3).
  3. Reachable by telephone (Phase 1 and 3).
  4. Provides frequent tangible support to an individual with diabetes such as assisting with activities of daily living (Phase 1 and 3).
  5. Assisted a participant during Phase 2 of the study (Phase 3).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506776


Locations
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Canada, Newfoundland and Labrador
Memorial University
St. John's, Newfoundland and Labrador, Canada, A1B 1P5
Sponsors and Collaborators
Memorial University of Newfoundland
Health Care Foundation, NL, Canada
Association of Registered Nurses of Newfoundland and Labrador
NL-SUPPORT, NL, Canada
Investigators
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Principal Investigator: Kathleen Stevens, PhD(c) Memorial University of Newfoundland and Labrador
Publications:
Statistics Canada. Diabetes by age group and sex [table]. http://Www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health53a-eng.htm. 2014.
Canadian Diabetes Association. Economic tsunami: The cost of diabetes in canada. www.diabetes.ca/publications-newsletters/advocacy-reports/economic-tsunami-the-cost-of-diabetes-in-canada; . 2009.
Canadian Association of Wound Care. Statistics. http://Cawc.net/index.php/public/facts-stats-and-tools/statistics/. 2015.
Canadian Diabetes Association. Canadian diabetes association's position statement on amputation prevention.http://Www.diabetes.ca/about-cda/public-policy-position-statements/amputation-prevention. 2015.

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Responsible Party: Kathleen Stevens, Assistant Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03506776    
Other Study ID Numbers: MemorialUN
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies