Diabetes Mellitus, Type 2PEDALNCT04327622
Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Deformities
- How many people
- 5,084 participants
- Where
- 1 siteCanada
- Study dates
- 3 Mar 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Prior diabetes foot assessment by an LMC chiropodist
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Deformities, Onychauxis, Neuropathy, Diabetic, Hyperkeratosis
- Keywords
- Diabetes, Observational Study, Diabetic Foot Complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Deformities, Nails, Malformed, Diabetic Neuropathies, Keratoderma, Palmoplantar, Epidermolytic, Onychomycosis, Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diabetes foot complications: foot ulcer
Proportion of patients diagnosed with a foot ulcer
Measured: 24-hours
Prevalence of diabetes foot complications: onychocryptosis
Proportion of patients with onychocryptosis
Measured: 24-hours
Prevalence of diabetes foot complications: onychomycosis
Proportion of patients with onychomycosis
Measured: 24-hours
Prevalence of diabetes foot complications: onychauxis
Proportion of patients with onychauxis
Measured: 24-hours
Prevalence of diabetes foot complications: hyperkeratosis
Proportion of patients with hyperkeratosis
Measured: 24-hours
Prevalence of diabetes foot complications: foot deformities
Proportion of patients with foot deformities
Measured: 24-hours
Prevalence of diabetes foot complications: neuropathy risk
Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS)
Measured: 24-hours
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start3 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronnie Aronson, MD, Principal investigator, LMC Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327622
- Sponsor's protocol ID
- PEDAL
- Acronym
- PEDAL
- Status last verified
- Apr 2020
- First submitted
- 27 Mar 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population
- ClinicalTrials.gov ID
- NCT04327622
- Acronym / sponsor ID
- PEDAL / PEDAL
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Deformities, Onychauxis, Neuropathy, Diabetic, Hyperkeratosis
- Keywords
- Diabetes, Observational Study, Diabetic Foot Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,084 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Prior diabetes foot assessment by an LMC chiropodist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of diabetes foot complications: foot ulcer
Time frame: 24-hours
Proportion of patients diagnosed with a foot ulcer
Prevalence of diabetes foot complications: onychocryptosis
Time frame: 24-hours
Proportion of patients with onychocryptosis
Prevalence of diabetes foot complications: onychomycosis
Time frame: 24-hours
Proportion of patients with onychomycosis
Prevalence of diabetes foot complications: onychauxis
Time frame: 24-hours
Proportion of patients with onychauxis
Prevalence of diabetes foot complications: hyperkeratosis
Time frame: 24-hours
Proportion of patients with hyperkeratosis
Prevalence of diabetes foot complications: foot deformities
Time frame: 24-hours
Proportion of patients with foot deformities
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)
2 secondary outcomes
Diabetes foot assessment risk group
Time frame: 24-hours
Association between foot risk variables and the presence of a foot ulcer
Time frame: 24-hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Aronson, MD principal investigator
LMC Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of diabetes foot complications: foot ulcer (time frame: 24-hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.