Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2OnychauxisFoot DeformitiesFoot Ulcer, DiabeticNeuropathy, DiabeticHyperkeratosisOnychomycosis
- Registration Number
- NCT04327622
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5084
- 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
- Prior diabetes foot assessment by an LMC chiropodist
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of diabetes foot complications: hyperkeratosis 24-hours Proportion of patients with hyperkeratosis
Prevalence of diabetes foot complications: onychauxis 24-hours Proportion of patients with onychauxis
Prevalence of diabetes foot complications: foot deformities 24-hours Proportion of patients with foot deformities
Prevalence of diabetes foot complications: foot ulcer 24-hours Proportion of patients diagnosed with a foot ulcer
Prevalence of diabetes foot complications: onychocryptosis 24-hours Proportion of patients with onychocryptosis
Prevalence of diabetes foot complications: onychomycosis 24-hours Proportion of patients with onychomycosis
Prevalence of diabetes foot complications: neuropathy risk 24-hours Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS)
- Secondary Outcome Measures
Name Time Method Association between foot risk variables and the presence of a foot ulcer 24-hours Risk factors that are associated with foot ulcers in our patient cohort with diabetes will be reported.
Diabetes foot assessment risk group 24-hours 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.
Trial Locations
- Locations (1)
LMC Healthcare
🇨🇦Toronto, Canada