The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients
NCT Number: NCT06464250
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Wound|Diabetic Foot Ulcer|Ulcer
Interventions: OTHER: Bundla care group
Sponsor: Marmara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 97
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-09-01
Completion Date: 2024-02-29
Locations: Başakşehir Çam ve Sakura City Hospital, İstanbul, 34000, Turkey

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.

Primary Outcome Measures: 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|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|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