Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population

Study Overview
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Brief Summary
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The study aims to assess foot complications among patients with diabetes in Canada, using patient data collected during diabetes foot assessments performed by the LMC Chiropody Team between February 27, 2018 and April 17, 2019.

Detailed Description
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Among patients with diabetes, one of the major causes of increased morbidity and mortality include lower-extremity complications. Patients who have peripheral neuropathy and peripheral arterial disease are at risk of developing foot ulcers and infection, which can lead to lower-extremity amputations. Adults with diabetes in Canada are 20 times more likely to be hospitalized for a nontraumatic lower limb amputation than adults without diabetes. Thus, the prevention, education and early treatment of diabetes foot complications are an important component of caring for patients living with diabetes. In addition to neuropathy and peripheral arterial disease, risk factors for developing foot ulcers include increased levels of glycated hemoglobin, onychomycosis, microvascular complications, previous foot ulcer or amputation, structural deformity, and limited joint mobility. To the best of our knowledge, the prevalence of foot complications, such as onychomycosis, and the association of diabetes foot complications with glycemic control and other diabetes risk factors, has not been assessed before in a large sample of Canadian patients. To better understand foot complications among patients with diabetes in Canada, the investigators will retrospectively examine patient data collected during diabetes foot assessments performed by the LMC Chiropody Team. The LMC Chiropody Team is part of LMC Diabetes & Endocrinology, which is one of the largest endocrine practice groups globally.

Official Title
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Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Deformities, Onychauxis, Neuropathy, Diabetic, Hyperkeratosis, Onychomycosis, Foot Ulcer, Diabetic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of type 1 or type 2 diabetes Under the care of an endocrinologist at LMC Diabetes foot assessment was performed by the LMC Chiropody Team Informed consent to use patient medical record data for research purposes was provided Exclusion Criteria: Prior diabetes foot assessment by an LMC chiropodist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of diabetes foot complications: foot ulcer | Proportion of patients diagnosed with a foot ulcer | 24-hours | 
| Prevalence of diabetes foot complications: onychocryptosis | Proportion of patients with onychocryptosis | 24-hours | 
| Prevalence of diabetes foot complications: onychomycosis | Proportion of patients with onychomycosis | 24-hours | 
| Prevalence of diabetes foot complications: onychauxis | Proportion of patients with onychauxis | 24-hours | 
| Prevalence of diabetes foot complications: hyperkeratosis | Proportion of patients with hyperkeratosis | 24-hours | 
| Prevalence of diabetes foot complications: foot deformities | Proportion of patients with foot deformities | 24-hours | 
| Prevalence of diabetes foot complications: neuropathy risk | Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS) | 24-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes foot assessment risk group | Diabetes foot assessment risk group will be determined according to International Diabetes Federation (IDF) recommendations. Proportion of patients with low, moderate, high and very high risk will be reported. | 24-hours | 
| Association between foot risk variables and the presence of a foot ulcer | Risk factors that are associated with foot ulcers in our patient cohort with diabetes will be reported. | 24-hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Observational Study, Diabetic Foot Complications