- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327622
Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population (PEDAL)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Toronto, Canada
- LMC Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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24-hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Foot Diseases
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Tinea
- Dermatomycoses
- Nail Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetic Foot
- Foot Ulcer
- Diabetes Mellitus, Type 1
- Onychomycosis
- Diabetic Neuropathies
- Diabetes Complications
- Foot Deformities
Other Study ID Numbers
- PEDAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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