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NCT Number: NCT06464250

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

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.

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Key information

Conditions

Wound Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam ve Sakura City Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bundla care group

Other

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

Primary outcomes

  1. individual benefit

    Time frame: at the end of three months

    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.

  2. social benefit

    Time frame: at the end of three months

    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.

  3. scientific utility

    Time frame: at the end of three months

    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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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