NCT07385833

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 26, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • Change in Disaster Preparedness Level

    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 Outcomes (3)

  • Change in Diabetic Foot Care Self-Efficacy

    Baseline, Week 3 (post-intervention), and Week 7 (follow-up

  • Change in Foot Self-Care Behaviors

    Baseline, Week 3 (post-intervention), and Week 7 (follow-up)

  • Preparation of an Emergency Kit/Go-Bag

    Week 3 (post-intervention)

Study Arms (2)

Disaster Preparedness Education Program

OTHER

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

Routine Care (Control)

NO INTERVENTION

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.

Interventions

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.

Disaster Preparedness Education Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 4, 2026

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

January 1, 2025

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data are available from the corresponding author upon reasonable request

Locations