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临床试验/NCT04480801
NCT04480801已完成不适用

The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer: Randomized Controlled Trial

Fatma Özkal2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Percentage of patients developing a foot ulcer

研究概览

简要总结

The study was planned as a prospective randomized controlled clinical trial to determine the effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II Diabetes Mellitus (DM).

详细描述

Diabetes Mellitus (DM) is a chronic disease caused by insufficient production of insulin hormone in the pancreas gland or inefficient use of the insulin produced. Diabetic neuropathy that occurs in 60-70% of patients with DM is reported to be the most important factor increasing the risk of diabetic foot. Determining risk factors in diabetic foot and attempting to eliminate or mitigate these factors have been found to be a simple, inexpensive and evidence-based tool that can be used at home by patients. This study will contribute to the current literature on the effectiveness of thermal assessment in preventing diabetic foot ulcers. The study was planned as a prospective randomized controlled clinical trial to determine the effect of thermal assessment on preventing diabetic foot ulcers in patients with Type II Diabetes Mellitus (DM). For the sample of the study, compared to those with thermal evaluation, the study reported that the probability of developing diabetic feet was 10.3 times higher than those without thermal evaluation program, 48 patients (thermal evaluation group: 24 people; control group: 24 people) were included in the study. It was decided that 30 patients were lost during data collection and 35 patients were included in each study group and the study was completed with a total of 70 patients. The patients included in the study will be assigned to the experimental group (thermal evaluation group) and control group by block randomization method according to the randomization list in a ratio of 1: 1. In the study, block randomization was performed by a statistician based on the current disease year (diabetes year) and the degree of diabetic foot risk.

For the implementation of the study, permission was obtained from the ethics committee of Necmettin Erbakan University Meram Medical Faculty, Non-Drug and Medical Device Research Ethics Committee, and work permit was obtained from Necmettin Erbakan University Meram Medical Faculty Hospital Chief Physician. Patients included in the study sample will be informed before the study that the purpose of the study and participation in the study is in line with the principle of volunteering, and "Informing and Consent of Volunteers Consent Form" will be signed.

Data collection tools;

  • Personal Information Form,
  • Chart to Record Diabetic Foot Risk Assessment Findings
  • Structured Daily Foot Care Form,
  • Evaluation Charts to be Given to Patients During Discharge

Independent variables

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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 and over
  • Volunteer
  • Sign the informed consent form
  • Diagnosed with type II Diabetes Mellitus
  • No diabetic foot ulcer
  • Patients with no foot or toe amputation will be admitted.

排除标准

  • Does not sign the informed consent form
  • Without a smart phone
  • Diagnosed with Type I Diabetes Mellitus,
  • Patients with diabetic foot ulcers
  • With ankle / arm index <0.9 and >1.30,

结局指标

主要结局

Percentage of patients developing a foot ulcer

时间窗: 2 months after the first assessment

There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.

次要结局

  • Changes in blood sugar values(2-month intervals until 1-year follow-up)
  • Change in foot care practices(2-month intervals until 1-year follow-up)

研究者

发起方
Fatma Özkal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Özkal

Lecturer

Necmettin Erbakan University

研究点 (2)

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