Disaster Preparedness in Patients With Diabetic Foot: The Effect of an Educational Intervention (Intervention)

February 3, 2026 updated by: Senem Duman
This quasi-experimental study aims to evaluate the effect of a disaster preparedness education program on disaster preparedness levels, foot care behaviors, and diabetic foot care self-efficacy in patients with type 2 diabetes diagnosed with diabetic foot. Participants are assigned to an intervention group receiving structured education on diabetic foot management and disaster preparedness, or to a control group receiving routine care. Outcomes are assessed at baseline, post-intervention, and follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with diabetic foot are considered a vulnerable population during disasters due to disrupted access to healthcare, medications, and self-care resources. This study evaluates a structured disaster preparedness education program designed specifically for patients with diabetic foot. The intervention includes education on diabetic foot management, disaster preparedness strategies, and preparation of emergency kits and go-bags. The effects of the program on disaster preparedness, foot self-care behaviors, and self-efficacy are assessed using validated measurement tools across three time points. The findings aim to contribute to the development of disaster-focused educational interventions for individuals with chronic conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Diagnosed with type 2 diabetes mellitus for at least 6 months

    • Diagnosed with diabetic foot classified as Wagner grade 1, 2, or 3
    • Receiving outpatient or inpatient care at the diabetic foot center
    • Able to communicate and complete self-report questionnaires
    • Willing to participate and provide written informed consent

Exclusion Criteria:

  • • History of diabetic foot-related amputation

    • Presence of active Charcot neuroarthropathy
    • Severe cognitive impairment affecting participation
    • Significant communication barriers preventing completion of assessments
    • Presence of acute medical conditions requiring immediate intensive treatment during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Disaster Preparedness Education Program
The intervention consists of two face-to-face theoretical education sessions delivered over two weeks. Week 1 includes a 2-hour session on diabetic foot management (definition, risk factors, care principles) supported by visual materials and interactive Q&A. Week 2 includes a session on disaster and emergency management for individuals with diabetic foot, covering preparedness before disasters, actions during disasters, and post-disaster strategies to protect foot health. The contents of an emergency kit/go-bag are physically demonstrated, and participants are asked to prepare their own kit and bring it to the next visit. At post-test, emergency kits/go-bags are inspected using a standardized checklist and feedback is provided for missing or incorrect items.
Behavioral: Disaster Preparedness Education Program
The intervention consists of two face-to-face theoretical education sessions delivered over two weeks. Week 1 includes a 2-hour session on diabetic foot management (definition, risk factors, care principles) supported by visual materials and interactive Q&A. Week 2 includes a session on disaster and emergency management for individuals with diabetic foot, covering preparedness before disasters, actions during disasters, and post-disaster strategies to protect foot health. The contents of an emergency kit/go-bag are physically demonstrated, and participants are asked to prepare their own kit and bring it to the next visit. At post-test, emergency kits/go-bags are inspected using a standardized checklist and feedback is provided for missing or incorrect items.
No Intervention: Routine Care (Control)
Participants receive routine diabetes care and follow-up as provided by the institution. No structured education on disaster preparedness or foot self-care behaviors is delivered during the study period. Data are collected at the same time points as the intervention group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Disaster Preparedness Level
Time Frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up)
Disaster preparedness level is measured using the Disaster Preparedness Scale (DPS), a 15-item validated self-report scale assessing disaster physical protection, disaster planning, disaster assistance, and disaster warning and signals. Total scores range from 15 to 60, with higher scores indicating greater disaster preparedness. The primary outcome is the change in DPS total score from baseline.
Baseline, Week 3 (post-intervention), and Week 7 (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Diabetic Foot Care Self-Efficacy
Time Frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up
Diabetic foot care self-efficacy is measured using the Diabetic Foot Care Self-Efficacy Scale (DFCSES), a validated self-report scale assessing confidence in performing diabetic foot care activities. Total scores range from 0 to 100, with higher scores indicating greater self-efficacy. The outcome is the change in DFCSES total score from baseline.
Baseline, Week 3 (post-intervention), and Week 7 (follow-up
Change in Foot Self-Care Behaviors
Time Frame: Baseline, Week 3 (post-intervention), and Week 7 (follow-up)
Foot self-care behaviors are measured using the Foot Self-Care Behavior Scale (FSCBS), a validated 15-item scale assessing the frequency of diabetic foot care behaviors. Total scores range from 15 to 75, with higher scores indicating more positive foot self-care behaviors. The outcome is the change in FSCBS total score from baseline.
Baseline, Week 3 (post-intervention), and Week 7 (follow-up)
Preparation of an Emergency Kit/Go-Bag
Time Frame: Week 3 (post-intervention)
Preparation of an emergency kit/go-bag is assessed by direct inspection using a standardized checklist developed according to national and international disaster preparedness guidelines. The outcome is defined as the proportion of participants who prepared a complete emergency kit/go-bag following the educational intervention.
Week 3 (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Senem Duman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Abbas, Z. G., & Gangji, R. R. (2025). The diabetic foot: Progress in Sub-Saharan Africa. Diabetes Research and Clinical Practice, 225, 112264. https://doi.org/10.1016/j.diabres.2025.112264 Allweiss, P. (2019). Diabetes and disasters: Recent studies and resources for preparedness. Current Diabetes Reports, 19(11), 131. https://doi.org/10.1007/s11892-019-1258-7 Alsararatee, H. H., Langley, J. C. S., Thorburn, M., Burton-Gow, H., Whitby, S., & Powell, S. (2025). Assessment of the diabetic foot in inpatients. British Journal of Nursing, 34(4), S12-S23. https://doi.org/10.12968/bjon.2024.0342 Armstrong, D. G., Tan, T. W., Boulton, A. J. M., & Bus, S. A. (2023). Diabetic foot ulcers: A review. JAMA, 330(1), 62-75. https://doi.org/10.1001/jama.2023.10578 Aziz, A. R. A., & Alsabek, M. B. (2020). Diabetic foot and disaster: Risk factors for amputation during the Syrian crisis. Journal of Diabetes and Its Complications, 34(2), 107493. https://doi.org/10.1016/j.jdiacomp.2019.107493 Bahador, R. S., Afrazandeh, S. S., Ghanbarzehi, N., & Ebrahimi, M. (2017). The impact of a three-month training programme on foot care and self-efficacy of patients with diabetic foot ulcers. Journal of Clinical and Diagnostic Research, 11(7), IC01-IC04. Bandura, A. (1977). Self-efficacy: Toward a unifying theory of behavioral change. Psychological Review, 84(2), 191-215.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SaglikBilimleriU-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available from the corresponding author upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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