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

Diabetes Mellitus, Type 2 Clinical Trial

— PEDAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327622
• Other study ID #: PEDAL
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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