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

Sponsor

LMC Diabetes & Endocrinology Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT04327622

Collaborator

(none)

5,084

Enrollment

Location

3.9

Actual Duration (Months)

1300.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Foot Deformities Onychauxis Neuropathy, Diabetic Hyperkeratosis Onychomycosis Foot Ulcer, Diabetic

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 Design

Study Type:

Observational

Actual Enrollment :

5084 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 3, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

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: onychauxis [24-hours]
Proportion of patients with onychauxis
Prevalence of diabetes foot complications: hyperkeratosis [24-hours]
Proportion of patients with hyperkeratosis
Prevalence of diabetes foot complications: foot deformities [24-hours]
Proportion of patients with foot deformities
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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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