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临床试验/NCT04327622
NCT04327622已完成不适用

Prevalence and Risk Evaluation of Diabetic Complications of the Foot in A Large Canadian Population

LMC Diabetes & Endocrinology Ltd.1 个研究点 分布在 1 个国家目标入组 5,084 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,084
试验地点
1
主要终点
Prevalence of diabetes foot complications: hyperkeratosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Prior diabetes foot assessment by an LMC chiropodist

结局指标

主要结局

Prevalence of diabetes foot complications: hyperkeratosis

时间窗: 24-hours

Proportion of patients with hyperkeratosis

Prevalence of diabetes foot complications: onychauxis

时间窗: 24-hours

Proportion of patients with onychauxis

Prevalence of diabetes foot complications: foot deformities

时间窗: 24-hours

Proportion of patients with foot deformities

Prevalence of diabetes foot complications: foot ulcer

时间窗: 24-hours

Proportion of patients diagnosed with a foot ulcer

Prevalence of diabetes foot complications: onychocryptosis

时间窗: 24-hours

Proportion of patients with onychocryptosis

Prevalence of diabetes foot complications: onychomycosis

时间窗: 24-hours

Proportion of patients with onychomycosis

Prevalence of diabetes foot complications: neuropathy risk

时间窗: 24-hours

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

次要结局

  • Association between foot risk variables and the presence of a foot ulcer(24-hours)
  • Diabetes foot assessment risk group(24-hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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