An observational study in Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 and Foot Deformities, sponsored by LMC Diabetes & Endocrinology Ltd.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by LMC Diabetes & Endocrinology Ltd. · 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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 5,084 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →LMC Diabetes & Endocrinology Ltd. is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
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Patients with diabetes at LMC Diabetes \& Endocrinology, who were provided with an initial diabetes foot assessment supported by funding from Bausch Canada. The diabetes foot assessments were performed by the LMC Chiropody Team at seven of the Ontario LMC clinics between February 27, 2018 and April 17, 2019.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prevalence of diabetes foot complications: foot ulcer
Proportion of patients diagnosed with a foot ulcer
Time frame: 24-hours
Prevalence of diabetes foot complications: onychocryptosis
Proportion of patients with onychocryptosis
Time frame: 24-hours
Prevalence of diabetes foot complications: onychomycosis
Proportion of patients with onychomycosis
Time frame: 24-hours
Prevalence of diabetes foot complications: onychauxis
Proportion of patients with onychauxis
Time frame: 24-hours
Prevalence of diabetes foot complications: hyperkeratosis
Proportion of patients with hyperkeratosis
Time frame: 24-hours
Prevalence of diabetes foot complications: foot deformities
Proportion of patients with foot deformities
Time frame: 24-hours
Prevalence of diabetes foot complications: neuropathy risk
Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS)
Time frame: 24-hours
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.
Time frame: 24-hours
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.
Time frame: 24-hours
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2020 to primary completion in Jun 2020, 3 months.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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LMC Diabetes & Endocrinology Ltd.