WoundNCT06464250
The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients
A study testing Bundla care group in people with Wound and Diabetic Foot Ulcer, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Diabetic Foot Ulcer, Ulcer
- What is being tested?
- Bundla care group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam ve Sakura City Hospital
Istanbul, 34000
About this study
Official title: The Effect of Bundle Approach on Foot Care Behaviors and Wound Healing in Patients Applying to Diabetic Wound Outpatient Clinic
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.
Read more
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.
Read the 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
- Being tested
- Bundla care group
- Keywords
- Diabetic Foot, Diabetic Foot Ulcer, Wound, Ulcer, Bundle, Care Package Approach
- Medical subject headings
- Wounds and Injuries, Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundla care groupOther
A care package consisting of foot examination, correct foot care behaviours, and regular blood glucose monitoring was used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at the end of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Sep 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, there are two parallel groups as control and intervention groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cıgdem Yavuz Batmaz, Marmara University
- Investigators
- Çiğdem Yavuz Batmaz, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464250
- Sponsor's protocol ID
- DYCYBHBK01
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bundle Approach on Foot Care Behaviors and Wound Healing in Patients Applying to Diabetic Wound Outpatient Clinic
- ClinicalTrials.gov ID
- NCT06464250
- Acronym / sponsor ID
- DYCYBHBK01
- Conditions
- Wound, Diabetic Foot Ulcer, Ulcer
- Keywords
- Diabetic Foot, Diabetic Foot Ulcer, Wound, Ulcer, Bundle, Care Package Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study, there are two parallel groups as control and intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Bundle care group | Experimental | Other: Bundla care groupBefore 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundla care groupA care package consisting of foot examination, correct foot care behaviours, and regular blood glucose monitoring was used. | Other | Bundle care group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çiğdem Yavuz Batmaz principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundla care group in people with Wound and Diabetic Foot Ulcer, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
individual benefit (time frame: at the end of three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.