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The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thermal Evaluation and Foot Care
Foot Care
Sponsored by
Fatma Özkal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot focused on measuring Diabetes Mellitus, diabetic foot, risk factors, thermal evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,

Sites / Locations

  • Necmettin Erbakan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

thermal evaluation and foot care

foot care

Arm Description

Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months.

Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.

Outcomes

Primary Outcome Measures

Percentage of patients developing a foot ulcer
There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.

Secondary Outcome Measures

Changes in blood sugar values
Changes in blood sugar levels in both groups for 12 months every 2 months
Change in foot care practices
Change in foot care practices for 12 months every 2 months in both groups

Full Information

First Posted
July 2, 2020
Last Updated
August 28, 2023
Sponsor
Fatma Özkal
Collaborators
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT04480801
Brief Title
The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer
Official Title
The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatma Özkal
Collaborators
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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 Identifying features of patients Features of patients associated with Diabetes Mellitus and its treatment Diabetic foot risk assessment results Foot care initiatives Dependent Variables - Development of diabetic foot ulcer Evaluation of the Data In the evaluation of the descriptive data obtained from the research, number, percentage, average and standard deviation will be used; The conformity of the data to normal distribution will be determined by Kolmogorov-Smirnov test and normal distribution curve, Skewness and Kurtosis test, and when the data show normal distribution, parametric tests will be used, and nonparametric tests will be used in the analysis of data that do not conform to the normal distribution. Significance will be evaluated within the confidence interval of 95%, p <0.05 will be taken. İmplementation of the research After vascular evaluation, neuropathy evaluation, and physical evaluation of the foot, individuals with a diagnosis of type 2 diabetes aged 18 and over will be formed the sample group. Once the sample group is determined, participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months. Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
Keywords
Diabetes Mellitus, diabetic foot, risk factors, thermal evaluation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thermal evaluation and foot care
Arm Type
Experimental
Arm Description
Participants in the experimental group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone. Thermal evaluation will be done. The application of the thermal evaluation, the foot areas to be applied and how to record the results of the application will be taught to the patient and / or their relatives. In addition, the thermal evaluation video will be uploaded to the phone of the patient and / or their relative. While the participants in the experimental group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions, Thermal evaluation registration form, Daily step number registration form will be provided and participants will be invited to check every 2 months.
Arm Title
foot care
Arm Type
Other
Arm Description
Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. The foot care video will be uploaded to the patient and / or relative's phone.While the participants in the control group were discharged; Blood glucose monitoring chart, Checklist to record foot care interventions will be provided and participants will be invited to check every 2 months.
Intervention Type
Other
Intervention Name(s)
Thermal Evaluation and Foot Care
Intervention Description
Participants in the experimental group will be given foot care and thermal evaluation in the clinic and will be taught to the patient and / or their relatives. Thermal evaluation and foot care video will be uploaded to the patient and / or relative's phone.
Intervention Type
Other
Intervention Name(s)
Foot Care
Intervention Description
Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. Foot care video will be uploaded to the patient and / or relative's phone.
Primary Outcome Measure Information:
Title
Percentage of patients developing a foot ulcer
Description
There will be a correlation between diabetic foot development and high temperature values obtained from thermal evaluation.
Time Frame
2 months after the first assessment
Secondary Outcome Measure Information:
Title
Changes in blood sugar values
Description
Changes in blood sugar levels in both groups for 12 months every 2 months
Time Frame
2-month intervals until 1-year follow-up
Title
Change in foot care practices
Description
Change in foot care practices for 12 months every 2 months in both groups
Time Frame
2-month intervals until 1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FATMA ÖZKAL
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serpil YÜKSEL, Phd
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan University
City
Konya
ZIP/Postal Code
42080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol

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The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

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