Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Car… (NCT07563751) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot
Jordan400 participantsStarted 2026-05-01
Plain-language summary
This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility.
The educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period.
The findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years and older
* Diagnosed with diabetic foot
* Able to communicate effectively
* Willing to participate in the educational program
* Able to provide written informed consent
Exclusion Criteria:
* Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation
* Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments
* Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance
* Pregnant or lactating women
* Patients who refuse to provide informed consent or withdraw at any stage of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity Measured Using the Numeric Rating Scale (NRS)
Timeframe: Baseline and post-intervention (4-8 weeks).