Diabetic Foot
Conditions
Keywords
Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, Quality of Life, Diabetic foot
Brief 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.
Detailed description
Diabetic foot is one of the most serious and common complications of diabetes mellitus, often leading to infection, ulceration, hospitalization, and in severe cases, lower limb amputation. It significantly affects patients' physical, psychological, and social well-being, thereby reducing overall quality of life. Despite the availability of preventive guidelines, many patients continue to demonstrate inadequate foot self-care behaviors, poor adherence to management recommendations, and low self-efficacy in managing their condition. This study is designed as a randomized controlled trial to assess the effectiveness of a structured educational program on improving clinical and behavioral outcomes among adults with diabetic foot. The study will be conducted at selected healthcare settings, and eligible participants will be randomly allocated into either an intervention group or a control group using a predefined randomization method. The intervention group will receive a structured educational program delivered through planned teaching sessions. The program is based on evidence-based diabetic foot care guidelines and includes theoretical and practical components. Topics covered include diabetic foot anatomy and risk factors, daily foot inspection techniques, proper hygiene practices, nail and skin care, appropriate footwear selection, wound prevention strategies, glycemic control, and early recognition of complications. Educational materials such as brochures, demonstrations, and interactive discussions will be used to enhance understanding and adherence. The control group will receive routine care and standard education provided by the healthcare facility without additional structured intervention. Outcome measures will be assessed at baseline and post-intervention. The primary outcomes include: Pain intensity measured using a validated pain scale Self-efficacy assessed through a standardized self-efficacy instrument Foot self-care behaviors measured using a diabetic foot care behavior scale Health-related quality of life assessed using a validated quality of life questionnaire Data will be analyzed to determine the effectiveness of the structured educational program in improving these outcomes compared to routine care. The study is expected to provide evidence supporting the integration of structured educational programs into nursing practice to improve self-management, reduce complications, and enhance quality of life among patients with diabetic foot.
Interventions
BEHAVIORALStructured Educational Program
A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management. The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications. Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
Sponsors
Jerash Private University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking will be applied. Participants and investigators will be aware of group assignments due to the nature of the educational intervention.
Intervention model description
This is a randomized controlled trial with two parallel groups: an intervention group receiving a structured educational program and a control group receiving routine care. Participants will be assigned to groups using random allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measured Using the Numeric Rating Scale (NRS) | Baseline and post-intervention (4-8 weeks). | Change in pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES) | Baseline and post-intervention (4-8 weeks). | Change in diabetes self-efficacy measured using the Diabetes Self-Efficacy Scale (DSES). The scale consists of 8 items assessing patients' confidence in managing diabetes-related self-care behaviors. Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident). Total scores range from 8 to 40, with higher scores indicating higher self-efficacy. |
Countries
Jordan
Contacts
CONTACTJawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
PRINCIPAL_INVESTIGATORJawad AHMAD Ahmed, Asst.Prof.Dr
Jerash University, Faculty of Nursing
Outcome results
None listed