Clinical trial NCT04327622: Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
Official title: Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Foot Deformities
Onychauxis
Neuropathy, Diabetic
Hyperkeratosis
Onychomycosis
Foot Ulcer, Diabetic
Keywords: Diabetes
Observational Study
Diabetic Foot Complications
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 5084
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes at LMC Diabetes \& Endocrinology, who were provided with an initial diabetes foot assessment supported by funding from Bausch Canada. The diabetes foot assessments were performed by the LMC Chiropody Team at seven of the Ontario LMC clinics between February 27, 2018 and April 17, 2019.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of diabetes foot complications: foot ulcer
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: onychocryptosis
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: onychomycosis
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: onychauxis
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: hyperkeratosis
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: foot deformities
timeFrame: 24-hours
measure: Prevalence of diabetes foot complications: neuropathy risk
timeFrame: 24-hours
Secondary outcomes:
measure: Diabetes foot assessment risk group
timeFrame: 24-hours
measure: Association between foot risk variables and the presence of a foot ulcer
timeFrame: 24-hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: LMC Healthcare
Study officials:
affiliation: LMC Healthcare
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References: