The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients

Diabetic Foot Ulcer Clinical Trial

Official title:

The Effect of Bundle Approach on Foot Care Behaviors and Wound Healing in Patients Applying to Diabetic Wound Outpatient Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06464250
• Other study ID #: DYCYBHBK01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: June 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to standardize foot care behaviors with a patient-participated care package approach, to ensure healing of existing wounds, and to evaluate the effect on foot care behaviors to prevent the development of new diabetic foot ulcers. The sample of the study consisted of a total of 97 patients, 49 patients in the care package group and 48 patients in the control group.

Hypotheses of the Study H1. The foot care behaviors of patients who receive a patient-participatory care package approach to diabetic foot ulcer prevention will be higher than those of patients who do not receive a care package.

H2. Patient-involved care package approach prevents the development of new diabetic foot ulcers.

H3. Patient-involved care package approach provides healing of existing diabetic ulcers.

Description:

The research was planned as a randomized controlled experimental study to standardize foot care behaviors with a care package approach consisting of evidence-based practices for patients with diabetic ulcers who applied to Başakşehir Çam and Sakura City Hospital diabetic wound outpatient clinic in Istanbul, to ensure healing of existing wounds, to prevent new diabetic foot ulcers, and to evaluate the effect on foot care behaviors. The average number of patients with diabetic foot ulcers 1-2 and 3 according to the Wagner classification is 300 people. According to the Power analysis (G*Power 3.1.9.7), it was aimed to reach at least 95 people in total with an effect size of 0.458, 5% margin of error and 95% power.Data were collected by the researcher through face-to-face interviews with the patient. "Patient Identification Form", "Nottingham Functional Foot Care Diagnosis Form (NAFF)", "Diabetic Foot Evaluation and Follow-up Form" were used. The patient identification form consists of 17 questions as a result of literature review. The Nottingham Assessment of Functional Footcare (NAFF) was developed by Lincon et al. in 2007 and focuses on foot care behaviors. "Diabetic foot assessment and follow-up form" was created by the researcher and the depth, length and width of the wound were measured to observe whether new wounds were formed and the healing status of the wound. Spearman Correlation Test was used to analyze the measured data with each other. P-values below 0.05 were considered as statistically significant results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age,

• No reading and comprehension problems,

• No psychiatric disorders,

• Wounds with Wagner 1-2 and 3 according to the Wagner classification (

• Individuals who agreed to participate in the study.

Exclusion Criteria:

• Under 18,

• Wounds other than diabetic ulcers,

• Wounds with Wagner 4 and Wagner 5 according to the Wagner classification (this wound class includes ischemic wounds),

• Below/above knee amputation in the limb other than the at-risk/injured foot,

• Psychiatric problems,

• Refuses to work or wants to leave during the work,

• Individuals with reading and comprehension problems.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer
• Wound
• Wounds and Injuries

Intervention

Other:
• Bundla care group
A care package consisting of foot examination, correct foot care behaviours, and regular blood glucose monitoring was used.

Locations

Country	Name	City	State
Turkey	Basaksehir Çam ve Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	individual benefit	It is useful for individuals with diabetic foot wounds to gain positive behaviors and reduce the development of complications.Through the Nottingham Assessment of Functional Footcare (NAFF), it is assessed that the individual gains positive foot care behaviors. The existing wound of the individual who gains positive foot care behaviors improves, new wound formation is prevented, and diabetes is controlled. The Nottingham Assessment of Functional Footcare (NAFF) is based on individuals' responses on four Likert-type scales of foot care behavior, with each item scored from zero to three. A high score indicates positive foot care behavior.	at the end of three months
Primary	social benefit	The care package approach aims to reduce the development of diabetic foot ulcers in the community.The diabetic foot assessment and follow-up form was used to measure the depth, length and width of the wound to observe whether new wounds were formed and the healing status of the wound. The commonly used Wagner classification, which facilitates wound classification by grading the wound from 0 to 5, was used.With the care package approach, the individual knows the factors that may cause new wounds as a result of the positive behaviors he/she gains and prevents the formation of new wounds by behaving accordingly.	at the end of three months
Primary	scientific utility	The results of the literature review will contribute to further studies with individuals with diabetic foot ulcers and to the evaluation of the effectiveness of the care bundle approach. The care package has been studied in different fields but has been limited to individuals with diabetic foot. After the literature review and expert opinion, the effect of the care package on the foot care behaviors of patients with diabetes in the "Patient-participated diabetic foot ulcer preventive care package" will be evaluated on new wound formation and wound healing. Face-to-face data will be collected. "Nottingham Assessment of Functional Footcare" scale will be used for foot care behaviors and "Wagner classification" will be used for wound assessment.	at the end of three months