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

NCT06464250 | Completed

• 1 other identifier: DYCYBHBK01
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Diabetic Foot Ulcer; Ulcer

Keywords

Diabetic Foot; Diabetic Foot Ulcer; Wound; Ulcer; Bundle; Care Package Approach

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Bundle care group

EXPERIMENTAL

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.

Other: Bundla care group

Control Group

NO INTERVENTION

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.

Interventions

Bundla care group OTHER

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

Bundle care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Başakşehir Çam ve Sakura City Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wounds and Injuries; Diabetic Foot; Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Çiğdem Yavuz Batmaz

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the study, participant blinding was performed by ensuring that the participants did not know which group they were in
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: In the study, there are two parallel groups as control and intervention groups.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 18, 2024
• Study Start: September 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

TU (1)