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Diabetic FootNCT04480801

The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

A study testing Thermal Evaluation and Foot Care and Foot Care in people with Diabetic Foot, run by Fatma Özkal at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot
What is being tested?
Thermal Evaluation and Foot Care and Foot Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2020to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necmettin Erbakan University

    Konya, 42080

Other trials in Turkey (Türkiye)

About this study

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

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).

Read the 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.

Conditions
Diabetic Foot
Being tested
Thermal Evaluation and Foot Care, Foot Care
Keywords
Diabetes Mellitus, diabetic foot, risk factors, thermal evaluation
Medical subject headings
Diabetic Foot, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermal Evaluation and Foot CareOther

    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.

  • Foot CareOther

    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.

Study groups in NCT04480801
Study groupRoleWhat they receive
thermal evaluation and foot careExperimentalParticipants 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.
Receives: Other: Thermal Evaluation and Foot Care
foot careOtherParticipants 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.
Receives: Other: Foot Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients developing a foot ulcer

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

    Measured: 2 months after the first assessment

Secondary outcomes (2)
  1. Changes in blood sugar values

    Changes in blood sugar levels in both groups for 12 months every 2 months

    Measured: 2-month intervals until 1-year follow-up

  2. Change in foot care practices

    Change in foot care practices for 12 months every 2 months in both groups

    Measured: 2-month intervals until 1-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start15 Sep 2020
  3. Primary completion15 Jun 2022
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective randomized controlled clinical trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480801
Sponsor's protocol ID
FOzkal
Status last verified
Jul 2020
First submitted
2 Jul 2020
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol

Questions about this trial

What is this clinical trial studying?

A study testing Thermal Evaluation and Foot Care and Foot Care in people with Diabetic Foot, run by Fatma Özkal at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients developing a foot ulcer (time frame: 2 months after the first assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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