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NCT Number: NCT04327622

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Bacterial Infections and Mycoses Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatomycoses Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Deformities Foot Ulcer Foot Ulcer, Diabetic Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperkeratosis Immune System Diseases Infections Keratoderma, Palmoplantar Keratoderma, Palmoplantar, Diffuse Keratoderma, Palmoplantar, Epidermolytic Keratosis Leg Ulcer Metabolic Diseases Musculoskeletal Diseases Mycoses Nail Diseases Nails, Malformed Nervous System Diseases Neuromuscular Diseases Neuropathy, Diabetic Nutritional and Metabolic Diseases Onychauxis Onychomycosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Skin Diseases Skin Diseases, Genetic Skin Diseases, Infectious Skin Ulcer Skin and Connective Tissue Diseases Tinea Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Healthcare

Toronto, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of diabetes foot complications: foot ulcer

    Time frame: 24-hours

    Proportion of patients diagnosed with a foot ulcer

  2. Prevalence of diabetes foot complications: onychocryptosis

    Time frame: 24-hours

    Proportion of patients with onychocryptosis

  3. Prevalence of diabetes foot complications: onychomycosis

    Time frame: 24-hours

    Proportion of patients with onychomycosis

  4. Prevalence of diabetes foot complications: onychauxis

    Time frame: 24-hours

    Proportion of patients with onychauxis

  5. Prevalence of diabetes foot complications: hyperkeratosis

    Time frame: 24-hours

    Proportion of patients with hyperkeratosis

  6. Prevalence of diabetes foot complications: foot deformities

    Time frame: 24-hours

    Proportion of patients with foot deformities

  7. 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)

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Registry information

Acronym: PEDAL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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