- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07385833
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
68
Phase
- 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
-
-
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Ankara, Turkey (Türkiye)
- Ankara Etlik City Hospital
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-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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.
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Week 3 (post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 1, 2024
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
January 26, 2026
First Submitted That Met QC Criteria
February 3, 2026
First Posted (Actual)
February 4, 2026
Study Record Updates
Last Update Posted (Actual)
February 4, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Diabetic Angiopathies
- Diabetes Complications
- Skin Diseases
- Skin Ulcer
- Leg Ulcer
- Diabetic Neuropathies
- Foot Ulcer
- Nutritional and Metabolic Diseases
- Skin and Connective Tissue Diseases
- Diabetes Mellitus, Type 2
- Diabetic Foot
Other Study ID 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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