NCT04327622

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,084

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 25, 2021

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

March 27, 2020

Last Update Submit

February 24, 2021

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Foot DeformitiesOnychauxisNeuropathy, DiabeticHyperkeratosisOnychomycosisFoot Ulcer, Diabetic

Keywords

DiabetesObservational StudyDiabetic Foot Complications

Outcome Measures

Primary Outcomes (7)

  • Prevalence of diabetes foot complications: foot ulcer

    Proportion of patients diagnosed with a foot ulcer

    24-hours

  • Prevalence of diabetes foot complications: onychocryptosis

    Proportion of patients with onychocryptosis

    24-hours

  • Prevalence of diabetes foot complications: onychomycosis

    Proportion of patients with onychomycosis

    24-hours

  • Prevalence of diabetes foot complications: onychauxis

    Proportion of patients with onychauxis

    24-hours

  • Prevalence of diabetes foot complications: hyperkeratosis

    Proportion of patients with hyperkeratosis

    24-hours

  • Prevalence of diabetes foot complications: foot deformities

    Proportion of patients with foot deformities

    24-hours

  • Prevalence of diabetes foot complications: neuropathy risk

    Risk for neuropathy will be measured using the modified Toronto Clinical Neuropathy Score (mTCNS)

    24-hours

Secondary Outcomes (2)

  • Diabetes foot assessment risk group

    24-hours

  • Association between foot risk variables and the presence of a foot ulcer

    24-hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Prior diabetes foot assessment by an LMC chiropodist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMC Healthcare

Toronto, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Foot DeformitiesNails, MalformedDiabetic NeuropathiesKeratoderma, Palmoplantar, EpidermolyticOnychomycosisDiabetic FootDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsKeratoderma, Palmoplantar, DiffuseKeratoderma, PalmoplantarSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesKeratosisSkin DiseasesSkin and Connective Tissue DiseasesTineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin Ulcer

Study Officials

  • Ronnie Aronson, MD

    LMC Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

March 3, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

February 25, 2021

Record last verified: 2020-04

Locations

CA(1)