Diabetes Mellitus, Type 2 Clinical Trial
— PEDALOfficial title:
Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
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 |
Verified date | April 2020 |
Source | LMC Diabetes & Endocrinology Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | LMC Healthcare | Toronto |
Lead Sponsor | Collaborator |
---|---|
LMC Diabetes & Endocrinology Ltd. |
Canada,
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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