Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04480801 |
| Other study ID # |
FOzkal |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2020 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
July 2020 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
