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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04327622
Acronym
PEDAL
Enrollment
5084
Registered
2020-03-31
Start date
2020-03-03
Completion date
2020-06-30
Last updated
2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Diabetes, Observational Study, Diabetic Foot Complications

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.

Interventions

None listed

Sponsors

LMC Diabetes & Endocrinology Ltd.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of diabetes foot complications: neuropathy risk24-hoursRisk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS)
Prevalence of diabetes foot complications: hyperkeratosis24-hoursProportion of patients with hyperkeratosis
Prevalence of diabetes foot complications: foot deformities24-hoursProportion of patients with foot deformities
Prevalence of diabetes foot complications: foot ulcer24-hoursProportion of patients diagnosed with a foot ulcer
Prevalence of diabetes foot complications: onychocryptosis24-hoursProportion of patients with onychocryptosis
Prevalence of diabetes foot complications: onychomycosis24-hoursProportion of patients with onychomycosis
Prevalence of diabetes foot complications: onychauxis24-hoursProportion of patients with onychauxis

Secondary

MeasureTime frameDescription
Association between foot risk variables and the presence of a foot ulcer24-hoursRisk factors that are associated with foot ulcers in our patient cohort with diabetes will be reported.
Diabetes foot assessment risk group24-hoursDiabetes 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026