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Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm

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. Identifier: NCT03370237
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
St. Joseph's Healthcare Foundation
Information provided by (Responsible Party):
Elisabeth Harvey, Lawson Health Research Institute

Brief Summary:
The main objective of this research study is to validate the St Joseph's Health Care Harmonized Foot Ulcer Assessment and Stratification tool using inter-rater reliability technique to determine if the score would consistently be reproducible by examiners of different role (Nurse Practitioner, Family physician, Registered Nurse and Resident). A validated assessment tool allows collecting better quality data with high comparability which enhances quality of foot care and increases the credibility of the tool.

Condition or disease
Foot Ulcer, Diabetic

Detailed Description:

Diabetes mellitus (DM) is a chronic disease characterized by the human body's inability to maintain appropriate blood glucose levels ( Buse et al. 2011). When inadequately managed, diabetes results in poor glycemic control, which, if prolonged, results in diabetes-related complications (Stratton et al. 2000). Diabetes is the major cause of blindness, kidney failure, and non-traumatic amputation in Canadian adults (PHAC, 2011). Foot ulcers are the major causes of amputations. Foot ulcers arise from poor circulation associated with peripheral vascular disease and neuropathy, injury and infections. Diabetes affects circulation and immunity, and over time the sensory nerves in the hands and feet may be damaged.

There are more than 2.4 million Canadians living with diabetes, of which 1.2 million of them live in Ontario (MHLTC). Diabetes is the leading cause of non-traumatic lower limb amputation in Canadian adults, associated with approximately 70% of amputations performed in hospital. Compared to the general population, Canadian adults with diabetes are over 20 times more likely to undergo non-traumatic lower limb amputations, 85% of which are preceded by a foot ulcer (PHAC, 2011 and Singh et al.,2005). According to a recent report (CDA, 2016) commissioned by the Canadian Diabetes Association (CDA), of the 1.53 million people with diabetes in Ontario, between 16,600 and 27,600 were expected to have a diabetes foot ulcer in 2015. Of these, nearly 2,000 were expected to need to have a lower limb amputated as a result of their condition and those amputations are associated with almost 800 premature deaths. In Ontario, diabetic foot ulcers (DFU) currently impose direct health-care costs of between $320-400 million and indirect costs of between $35-60 million (Hopkins et al.,2015).

Strong evidence shows that up to 85% of diabetic foot amputations can be prevented, supporting the benefits of early recognition of diabetes-related foot complications (CDA, 2013). Furthermore, timely assessment, referral, and provision of evidence-informed foot care are cost saving for the healthcare system. Use of a standardized diabetic foot assessment tool is required to ensure consistent approach to risk recognition and provide a framework for care. In response to the need for a tool that facilitates a consistent and standard screening procedure, the Primary Care Diabetes Support Program (PCDSP) at St. Joseph's Health Care, London, Ontario developed an evidence based, multi-disciplinary foot ulcer assessment tool. The SJHC harmonized foot ulcer assessment tool was developed to aid in the early detection of diabetic foot problems and to ensure prompt referral to the right foot care provider for appropriate treatment, thereby improving outcomes of the diabetic foot.

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Reliability of a Diabetic Foot Ulcer Risk Stratification and Referral Algorithm
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 22, 2017
Actual Study Completion Date : September 22, 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Diabetic foot ulcer risk score [ Time Frame: on examination day ]
    The Diabetic Foot Ulcer Assessment tool used in this study has five scores (categories) ranging from 0(low risk) to 3A (high risk). The higher the score is the higher the risk for diabetic foot ulcer. Each care provider assessed participating patients for foot ulcer and assigned a score for each. The five scores are 0, 1,2A,2B and 3A.

Secondary Outcome Measures :
  1. Raters' level of confidence [ Time Frame: On examination day ]
    Raters (care providers) level of confidence in using the tool to assess diabetic foot and plan appropriate follow up

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with type 2 diabetes who have received diabetes care at the primary care diabetes support program in London Ontario, Canada.

Inclusion Criteria:

Patients with type 2 diabetes older than 18, living with diabetes for more than ten years and consented were included in the study as patient participants.

Care providers including family doctors, nurse practitioners, nurses and residents who provider diabetes care was including as care provider participants

Exclusion Criteria:

Patients with previous transfemoral or transtibial amputation or diagnosed with dementia or inability to speak English were excluded from the study

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 identifier (NCT number): NCT03370237

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Canada, Ontario
SJHC Primary Care Diabetes Support Program SJHC Family Medical and Dental Centre
London, Ontario, Canada, N6G 1J1
Sponsors and Collaborators
Lawson Health Research Institute
St. Joseph's Healthcare Foundation
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Principal Investigator: Betty Harvey Western University and St Joseph's Health Care London
Buse JB, Polonsky KS, Burant CF. Type 2 diabetes mellitus. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR. Williams Textbook of Endocrinology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011
Public Health Agency of Canada. Diabetes in Canada: Facts and Figures from a Public Health Perspective. Ottawa; 2011.
Ministry of Health and Long Term Care. Diabetes Management Strategy. Chapter 3 Section 3.03
Canadian Diabetes Association : Impact of offloading devices on the cost of diabetic foot ulcers in Ontario, Accessed on Sep 11 2016

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Responsible Party: Elisabeth Harvey, Adjunct Associate Professor, Lawson Health Research Institute Identifier: NCT03370237    
Other Study ID Numbers: 30
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elisabeth Harvey, Lawson Health Research Institute:
Diabetic foot ulcer
type 2 diabetes
foot ulcer risk
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases