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Diabetic Foot UlcerNCT06538168

Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes

A study testing Diabetes Self-Management Education (DSME) in people with Diabetic Foot Ulcer, run by Universiti Putra Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetes is a significant global health concern, affecting over half a billion people and leading to severe complications like diabetic foot ulcers (DFUs). The increasing incidence of DFUs highlights the need for ongoing research and effective prevention strategies. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Diabetes Self-Management Education (DSME)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,430 participants
Where
No sites listed yet
Study dates
30 Jul 2024to 25 Jun 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Presence of a diabetic foot wound corresponding to Warner 2 - 4 Continuous existence of the diabetic foot lesion for a minimum of 4 weeks < Participant has given written informed consent

Who cannot join

  • Age <18 years Pregnancy Present or expected non-compliance with the requirements of the study estimated by investigator at the time point of inclusion indication for amputation above the ankle level of the same Necrotic tissue with eschar present that cannot be debrided untreated osteitis or osteomyelitis Unexplored fistula
  • Malignancy of the wound Exposed nerves, vessels, or anastomotic areas
  • Ambulant negative pressure wound therapy of patients with anticoagulation therapy or higher grade impaired clotting function and a heightened risk for bleeding with relevant circulatory effects
  • Allergy to any disposal component of each treatment arm Severe anemia which is not caused by an infection
  • Simultaneous participation in other interventional trials / previous participation in this trial
  • Use of negative pressure wound therapy within 6 weeks before randomization

Trial locations and contacts

No sites are listed yet.

About this study

Official title: The Effect of a Comprehensive Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes

Diabetes is a significant global health concern, affecting over half a billion people and leading to severe complications like diabetic foot ulcers (DFUs). The increasing incidence of DFUs highlights the need for ongoing research and effective prevention strategies. A major challenge in managing DFUs is the inadequate preparation of healthcare professionals (HCPs) in delivering comprehensive diabetes self-management education (DSME). Enhancing the education and training of HCPs is essential to improve diabetes management and reduce DFUs.

Studies show that patients' knowledge and self-care practices vary widely, with common foot-care activities including washing, drying, applying moisturizer, and routine nail care. Improving these self-care practices is crucial for early recognition and management of DFUs to reduce the risk of amputations.

Read more

Health promotion models such as the Self-Efficacy Theory and Health Belief Model have shown promise in informing foot care interventions, but further research is needed to determine the most effective strategies. Previous research has several limitations, including selection bias, lack of consensus on outcome measures, and moderate risk of bias in some studies.

The proposed study will use an experimental design with a nonequivalent control group to assess the effectiveness of DSME in reducing non-ulcerated diabetic foot incidents. Data will be collected using the Diabetes Self-Care Activities Foot Care Questionnaire and analyzed with statistical tests. Ethical guidelines will be strictly followed, ensuring participant confidentiality and voluntary participation.

Overall, this research aims to address gaps in diabetes education and promote behavioral changes to improve diabetes care and reduce DFUs. Continuous training and education for HCPs are vital for enhancing their competence in managing DFUs and improving patient outcomes.

Read the detailed description

Diabetes is a major global health issue affecting over half a billion people worldwide, leading to serious complications such as diabetic foot ulcers (DFUs). The increasing incidence of DFUs necessitates further research to manage and prevent these severe complications. Healthcare professionals (HCPs) play a crucial role in addressing the rising incidence of diabetes and DFUs through capacity building and periodic education. However, many HCPs are inadequately prepared to deliver comprehensive diabetes self-management education (DSME), which is essential for preventing and treating DFUs.

The World Health Organization (WHO) reports that approximately 422 million people with diabetes live in low- and middle-income countries, with diabetes directly causing about 1.5 million deaths annually. Over the past few decades, there has been a consistent rise in both the incidence and prevalence of diabetes. This condition significantly contributes to renal disease, heart attacks, strokes, blindness, and lower extremities amputation, often resulting from infected foot ulcers. About 15% to 25% of diabetic patients develop foot ulcers at some point. Foot problems like ulcers, infections, and amputations are among the most significant complications of diabetes, but these issues can often be avoided with consistent foot care.

The study aims to understand how health promotion models have informed foot care interventions for older adults with diabetes. A review of 2,078 articles identified 31 studies that met eligibility criteria, focusing on foot care interventions for older adults. Most of these studies involved people with diabetes and used health promotion models such as the Self-Efficacy Theory and the Health Belief Model. The interventions showed promising outcomes in improving foot care for older adults, highlighting the need for further research to determine the most effective models and implementation strategies.

Previous research has several limitations: exclusion of relevant studies on intervention implementation, lack of consensus on foot-related outcome measures, selection bias due to convenience sampling techniques, cross-sectional designs making causal inferences impossible, moderate risk of bias in some studies, restriction to studies conducted between 2004 and 2022, lack of randomized or controlled samples in some studies, and immediate assessment of attitudes and skills post-training influencing health promotion models.

This research addresses the lack of diabetes education and the limited adoption of behavioral changes among the population, which lead to challenges in diabetes care. Effective education for healthcare professionals, communities, and patients is essential to improve diabetes management and reduce the risk of complications such as DFUs. The objectives of the study are to understand the contexts where health promotion models have informed foot care interventions, identify the health promotion models used in these interventions, and document the effectiveness of theoretically informed health promotion interventions in improving foot care for older adults.

Health promotion models like the Self-Efficacy Theory and the Health Belief Model have shown promising outcomes in improving foot care behaviors and knowledge. The studies vary in intervention approaches, delivery methods, and outcome measurements, emphasizing the need for further research to determine the most effective models and implementation strategies. There is a strong correlation between high knowledge of foot care and good practice, with varying levels of knowledge and engagement in foot-care activities like washing, drying, applying moisturizer, and trimming nails.

The study will assess the impact of DSME on non-ulcer diabetic foot incidents through a structured research design and statistical analysis. A review of existing studies shows that appropriate foot care practices are essential for preventing complications like DFUs. Common self-care practices include washing feet with lukewarm water, drying thoroughly, using moisturizing cream, inspecting feet daily, nail care, and wearing suitable footwear. Outcome measures in these studies included foot health outcomes, knowledge of foot health, foot care behaviors, and self-efficacy. The need for standardized outcome measures and further research on the effectiveness and cost-benefit of foot care interventions for older adults is highlighted.

The study will use an experimental design with a nonequivalent control group. Consecutive sampling will divide 230 participants into intervention and control groups. The Diabetes Self-Care Activities Foot Care Questionnaire will be used as the research instrument. Statistical analyses will include the Wilcoxon Signed Ranks Test and Mann-Whitney Test to compare the mean incidence of non-ulcerated diabetic foot incidents before and after the intervention.

The research will adhere to ethical guidelines, ensuring participant confidentiality, voluntary participation, and informed consent. Participants will be assured of their right to withdraw from the study at any time without any penalties.

Overall, this research aims to enhance diabetes education and promote behavioral changes to improve diabetes care and reduce the incidence of DFUs. Continuous training and education for HCPs are crucial for improving their competence in managing DFUs and achieving better patient outcomes.

Being tested
Diabetes Self-Management Education (DSME)
Medical subject headings
Diabetic Foot

What participants receive

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

  • Diabetes Self-Management Education (DSME)Behavioural

    The intervention, Diabetes Self-Management Education (DSME), involves a structured educational program including daily reminders regarding medication, and foot care, educational-led video weekly, and handouts for the management od diabetes and foot care to enhance knowledge and skills in managing diabetes and preventing complications like diabetic foot ulcers (DFUs).

Study groups in NCT06538168
Study groupRoleWhat they receive
intervention groupExperimentalThe intervention group typically consists of participants who are subjected to the Diabetes Self-Management Education (DSME) program The intervention, Diabetes Self-Management Education (DSME), involves a structured educational program including daily reminders regarding medication, and foot care, educational-led video weekly, and handouts for the management of diabetes and foot care to enhance knowledge and skills in managing diabetes and preventing complications like diabetic foot ulcers (DFUs).
Receives: Behavioral: Diabetes Self-Management Education (DSME)
Control groupNo interventionThese participants do not receive any intervention.

What is being measured

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

  1. Knowledge of Diabetic foot

    Knowledge of Diabetic foot using a scale will be measured Likert Scale questions where participants rate their agreement with statements about foot care practices (e.g., "I always wear well-fitting shoes," with options ranging from "Strongly Disagree" to "Strongly Agree").

    The total score is then used to categorize the participant's knowledge level. This categorization can be study-specific, but some common examples include:

    • Low knowledge: Scoring less than 60% of questions correctly suggests a need for significant education on diabetic foot care.
    • Moderate knowledge: Scoring between 60% and 80% indicates some understanding but may benefit from further education.
    • High knowledge: Scoring above 80% suggests a good understanding of diabetic foot care principles.

    Measured: 12 months from baseline

  2. Health related quality of life

    Health related quality of life measured by EQ- 5D-3L. o measure the health-related quality of life at baseline, three-month, and 12-month post-intervention, EuroQol 5-Dimension- 3-level will be used. The European quality of life scale (EQ-5D-3L) has five dimensions and three levels. Each of the five dimensions comprising the EQ-5D descriptive system is divided into three levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating some problems LEVEL 3: indicating extreme problems, 1 (perfect health), with higher scores indicating higher health utility.

    2- On a 20 cm vertical visual analog scale, the EQ-VAS captures the patient's self-rated health, with two unique endpoints such as "Best imaginable health condition" for a score of 100 and "Worst imaginable health state" for a score of 0.

    Measured: 12 months from baseline

  3. Adherence to anti-diabetic medication

    The secondary outcome is the change in medication adherence to antihypertensive treatment. Using the "pills taken over a certain period, divided by pills prescribed for that specific period", the primary outcome will be measured.it will be self-reporting. A cut-off value of 80% has been established from previous literature. Non-adherents will make up less than 80% of the population, while adherents will make up more than 80%.

    Measured: 12 months from baseline

Secondary outcomes (4)
  1. Past 3 months glycemic control

    The out come will be measured by HbA1c

    Measured: 12 months from baseline

  2. Hospitalization

    measured by tracking for hospital admission

    Measured: 12 months from baseline

  3. Amputation status

    Amputation status measured by confirming hospital records

    Measured: 12 months from baseline

  4. Foot ulceration

    Foot ulceration will be measured by Wagner Wound Classification System Wagner Grade 0: Skin is intact with no open lesion or a pre-ulcerative lesion - may have a deformity or cellulitis Wagner Grade 1: Partial- or full-thickness ulcer (superficial ulcer) Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis (OM) Wagner Grade 3: Deep abscess, OM, or joint sepsis Wagner Grade 4: Partial-foot gangrene Wagner Grade 5: Whole-foot gangrene

    Measured: 12 months from baseline

Timeline

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

  1. First posted5 Aug 2024
  2. Study start30 Jul 2024 (estimated)
  3. Primary completion15 May 2025 (estimated)
  4. Study completion25 Jun 2025 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
In an interventional parallel study design, participants are assigned to either an intervention group and a control group. The intervention group receives the treatment or intervention being tested, while the control group does not receive the intervention and serves as a comparison. This allows researchers to assess the effectiveness of the intervention by comparing outcomes between the two groups under controlled conditions.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
2,430 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538168
Sponsor's protocol ID
UIPH
Status last verified
Jul 2024
First submitted
31 Jul 2024
Last updated
5 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ackermann RT, O'Brien MJ. Evidence and Challenges for Translation and Population Impact of the Diabetes Prevention Program. Curr Diab Rep. 2020 Feb 20;20(3):9. doi: 10.1007/s11892-020-1293-4.

    PubMed 32080770
  • Arumalla N, Chan CKD, Gibson M, Man YL, Adas MA, Norton S, Galloway JB, Garrood T. The Clinical Impact of Electronic Patient-Reported Outcome Measures in the Remote Monitoring of Inflammatory Arthritis: A Systematic Review and Meta-analysis. Arthritis Rheumatol. 2023 Nov;75(11):1892-1903. doi: 10.1002/art.42559. Epub 2023 Sep 18.

    PubMed 37204273
  • Geidne S, Kokko S, Lane A, Ooms L, Vuillemin A, Seghers J, Koski P, Kudlacek M, Johnson S, Van Hoye A. Health Promotion Interventions in Sports Clubs: Can We Talk About a Setting-Based Approach? A Systematic Mapping Review. Health Educ Behav. 2019 Aug;46(4):592-601. doi: 10.1177/1090198119831749. Epub 2019 Feb 22.

    PubMed 30795690

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Self-Management Education (DSME) in people with Diabetic Foot Ulcer, run by Universiti Putra Malaysia.

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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Fahmina Jamil (03264316905, Fahminajamil220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge of Diabetic foot (time frame: 12 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538168, which also lists 3 linked publications.

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 5 Aug 2024.

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