Clinical trial NCT06464250: The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients
Official title: The Effect of Bundle Approach on Foot Care Behaviors and Wound Healing in Patients Applying to Diabetic Wound Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Diabetic Foot Ulcer
Ulcer
Keywords: Diabetic Foot
Diabetic Foot Ulcer
Wound
Ulcer
Bundle
Care Package Approach
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the study, there are two parallel groups as control and intervention groups.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: individual benefit
timeFrame: at the end of three months
measure: social benefit
timeFrame: at the end of three months
measure: scientific utility
timeFrame: at the end of three months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Başakşehir Çam ve Sakura City Hospital
Study officials:
affiliation: Marmara University
name: Çiğdem Yavuz Batmaz
role: PRINCIPAL_INVESTIGATOR
References: