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

NCT03506776 | Completed

• 1 other identifier: MemorialUN
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• change from baseline foot assessment as evidenced by a diabetic foot ulcer

  Screening for the high risk diabetic foot: A 60 second foot tool (2012) Sibbald

  time to ulceration up to 24 weeks

Secondary Outcomes (2)

• change from baseline foot assessment as evidenced by presence or absence of skin breakdown

  Completed by participant daily up to 24 weeks

• change from baseline foot assessment evidenced by presence or absence of redness

  Completed by participant daily up to 24 weeks

Study Arms (2)

Education Only Group

ACTIVE COMPARATOR

The education only group will receive foot self-management education.

Other: Education Only Group

Education and Thermometer Group

EXPERIMENTAL

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

Interventions

Education and Thermometer Group DEVICE

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.

Also known as: Infrared Thermometer

Education and Thermometer Group

Education Only Group OTHER

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.

Education Only Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide care to diabetic individuals (Phase 1 only)
• 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)
• Were consulted by participants during the intervention (Phase 3 only)
• Patients (All Phases)
• Able to read and speak English
• Reachable by telephone
• years of age and older
• 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).
• Callus and/or
• Deformity and/or
• One areas of loss of sensation as determined by assessment with Semmes Weinstein Monofilament

You may not qualify if:

• Ulcer
• Amputation sites not healed
• Foot infections
• Charcot arthropathy
• 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)
• Major health conditions
• Inability to read the thermometer and no support person available to assist the participant with temperature reading and documentation on a daily basis
• 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)
• Unable to walk without assistance.
• Family/Support Persons (Phase 1 and 3)
• years of age and older (Phase 1 and 3).
• Able to read and speak English (Phase 1 and 3).
• Reachable by telephone (Phase 1 and 3).
• Provides frequent tangible support to an individual with diabetes such as assisting with activities of daily living (Phase 1 and 3).
• Assisted a participant during Phase 2 of the study (Phase 3).

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Health Care Foundation, NL, Canada: collaborator
• Association of Registered Nurses of Newfoundland and Labrador: collaborator
• NL-SUPPORT, NL, Canada: collaborator

Study Sites (1)

Memorial University

St. John's, Newfoundland and Labrador, A1B 1P5, Canada

Location

Related Publications (17)

• Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014 Feb;103(2):137-49. doi: 10.1016/j.diabres.2013.11.002. Epub 2013 Dec 1.

  PMID: 24630390 BACKGROUND

• Statistics Canada. Diabetes by age group and sex [table]. http://Www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health53a-eng.htm. 2014.

  BACKGROUND

• 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.

  BACKGROUND

• Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217.

  PMID: 15644549 BACKGROUND

• Hopkins RB, Burke N, Harlock J, Jegathisawaran J, Goeree R. Economic burden of illness associated with diabetic foot ulcers in Canada. BMC Health Serv Res. 2015 Jan 22;15:13. doi: 10.1186/s12913-015-0687-5.

  PMID: 25608648 BACKGROUND

• Canadian Association of Wound Care. Statistics. http://Cawc.net/index.php/public/facts-stats-and-tools/statistics/. 2015.

  BACKGROUND

• Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, Lemaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; American Diabetes Association; American Association of Clinical Endocrinologists. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008 Aug;31(8):1679-85. doi: 10.2337/dc08-9021. No abstract available.

  PMID: 18663232 BACKGROUND

• Chang CH, Peng YS, Chang CC, Chen MY. Useful screening tools for preventing foot problems of diabetics in rural areas: a cross-sectional study. BMC Public Health. 2013 Jun 27;13:612. doi: 10.1186/1471-2458-13-612.

  PMID: 23802741 BACKGROUND

• Delea S, Buckley C, Hanrahan A, McGreal G, Desmond D, McHugh S. Management of diabetic foot disease and amputation in the Irish health system: a qualitative study of patients' attitudes and experiences with health services. BMC Health Serv Res. 2015 Jul 1;15:251. doi: 10.1186/s12913-015-0926-9.

  PMID: 26129712 BACKGROUND

• Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, Athanasiou KA, Agrawal CM. Home monitoring of foot skin temperatures to prevent ulceration. Diabetes Care. 2004 Nov;27(11):2642-7. doi: 10.2337/diacare.27.11.2642.

  PMID: 15504999 BACKGROUND

• Arad Y, Fonseca V, Peters A, Vinik A. Beyond the monofilament for the insensate diabetic foot: a systematic review of randomized trials to prevent the occurrence of plantar foot ulcers in patients with diabetes. Diabetes Care. 2011 Apr;34(4):1041-6. doi: 10.2337/dc10-1666. No abstract available.

  PMID: 21447666 BACKGROUND

• Houghton VJ, Bower VM, Chant DC. Is an increase in skin temperature predictive of neuropathic foot ulceration in people with diabetes? A systematic review and meta-analysis. J Foot Ankle Res. 2013 Aug 7;6(1):31. doi: 10.1186/1757-1146-6-31.

  PMID: 23919736 BACKGROUND

• van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. doi: 10.1002/dmrr.2701.

  PMID: 26340966 BACKGROUND

• Mufti A, Coutts P, Sibbald RG. Validation of commercially available infrared thermometers for measuring skin surface temperature associated with deep and surrounding wound infection. Adv Skin Wound Care. 2015 Jan;28(1):11-6. doi: 10.1097/01.ASW.0000459039.81701.b2.

  PMID: 25502971 BACKGROUND

• 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.

  BACKGROUND

• Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, Armstrong DG, Agrawal CM. Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan;30(1):14-20. doi: 10.2337/dc06-1600.

  PMID: 17192326 BACKGROUND

• Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Am J Med. 2007 Dec;120(12):1042-6. doi: 10.1016/j.amjmed.2007.06.028.

  PMID: 18060924 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathleen Stevens, PhD(c)

  Memorial University of Newfoundland and Labrador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 24, 2018
• Study Start: August 21, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)