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

NCT ID: NCT06464250

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-02-29

Brief 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.

Detailed 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.

Conditions

Wound; Diabetic Foot Ulcer; Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Bundle care group

Before the intervention, both the Control and Intervention groups underwent face-to-face interviews and completed forms such as the 'Patient Identification Form,' 'Nottingham Functional Foot Care Diagnosis Form,' and 'Diabetic Foot Evaluation Form.' Subsequently, both groups received one-on-one training covering various aspects related to diabetic foot. This training, conducted by the researcher, involved interactive question-answer sessions and practical demonstrations of foot care techniques.

Following the training, the Intervention group received a care package comprising foot examination, guidance on correct foot care practices, and a request for regular blood glucose monitoring. These patients were then monitored at the 1st, 2nd, and 3rd months.

Group Type: EXPERIMENTAL

Bundla care group

Intervention Type: OTHER

A care package consisting of foot examination, correct foot care behaviours, and regular blood glucose monitoring was used.

Control Group

For the Control group, after receiving education and brochures, the 'Nottingham Functional Foot Care Diagnostic Form' and 'Diabetic Foot Evaluation Form' were completed at the 1st, 2nd, and 3rd months. Similar to the Intervention group, new wound formation, wound classification, and healing status of existing ulcers were monitored for this group as well.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bundla care group

A care package consisting of foot examination, correct foot care behaviours, and regular blood glucose monitoring was used.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Cıgdem Yavuz Batmaz

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Çiğdem Yavuz Batmaz

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Başakşehir Çam ve Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DYCYBHBK01

Identifier Type: -

Identifier Source: org_study_id