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

February 24, 2021 updated by: LMC Diabetes & Endocrinology Ltd.
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

5084

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toronto, Canada
        • LMC Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of diabetes foot complications: foot ulcer
Time Frame: 24-hours
Proportion of patients diagnosed with a foot ulcer
24-hours
Prevalence of diabetes foot complications: onychocryptosis
Time Frame: 24-hours
Proportion of patients with onychocryptosis
24-hours
Prevalence of diabetes foot complications: onychomycosis
Time Frame: 24-hours
Proportion of patients with onychomycosis
24-hours
Prevalence of diabetes foot complications: onychauxis
Time Frame: 24-hours
Proportion of patients with onychauxis
24-hours
Prevalence of diabetes foot complications: hyperkeratosis
Time Frame: 24-hours
Proportion of patients with hyperkeratosis
24-hours
Prevalence of diabetes foot complications: foot deformities
Time Frame: 24-hours
Proportion of patients with foot deformities
24-hours
Prevalence of diabetes foot complications: neuropathy risk
Time Frame: 24-hours
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
Time Frame: 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.
24-hours
Association between foot risk variables and the presence of a foot ulcer
Time Frame: 24-hours
Risk factors that are associated with foot ulcers in our patient cohort with diabetes will be reported.
24-hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 3, 2020

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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