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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04327622
Other study ID # PEDAL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2020
Est. completion date June 30, 2020

Study information

Verified date April 2020
Source LMC Diabetes & Endocrinology Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 5084
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Canada LMC Healthcare Toronto

Sponsors (1)

Lead Sponsor Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of diabetes foot complications: foot ulcer Proportion of patients diagnosed with a foot ulcer 24-hours
Primary Prevalence of diabetes foot complications: onychocryptosis Proportion of patients with onychocryptosis 24-hours
Primary Prevalence of diabetes foot complications: onychomycosis Proportion of patients with onychomycosis 24-hours
Primary Prevalence of diabetes foot complications: onychauxis Proportion of patients with onychauxis 24-hours
Primary Prevalence of diabetes foot complications: hyperkeratosis Proportion of patients with hyperkeratosis 24-hours
Primary Prevalence of diabetes foot complications: foot deformities Proportion of patients with foot deformities 24-hours
Primary Prevalence of diabetes foot complications: neuropathy risk Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS) 24-hours
Secondary Diabetes foot assessment risk group 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
Secondary Association between foot risk variables and the presence of a foot ulcer Risk factors that are associated with foot ulcers in our patient cohort with diabetes will be reported. 24-hours
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