Diabetic Foot UlcerNCT06037369
The Short Message-based Customized Standardized
A study testing customized standardized educational program sent by LINE software. in people with Diabetic Foot Ulcer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- customized standardized educational program sent by LINE software.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2023to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria are:
- Outpatients with foot ulcers
- Diagnosed as diabetic patients
- Can be interviewed in Mandarin or Taiwanese.
The exclusion criteria are:
- It is expected that there is no need to return to the clinic at the eighth week after the baseline, or the number of return visits within eight weeks will be less than two times
- Patient and family members living with him/her do not use a smart phone
- Being unable to read text messages on mobile phone, or with impaired hearing, could not answer the phone
- Impaired fine hand movements, unable to click on mobile phone text messages
- Unwilling to use the communication software LINE to receive text messages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Short Message-based Customized Standardized Education Program in Promoting Wound Healing and Quality of Life of Patients With Diabetic Foot Ulcers
The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.
A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.
Read the detailed description
The diabetic foot ulcer need complex treatment, and is with poor prognosis, thus it consumes medical resources and impedes the quality of life of patients. Most of the time, patients are required to perform diabetic foot ulcer self-management at home. However, their self-management behaviors are inadequate.
Individualized patient education message can promote and maintain appropriate diabetes self-management behaviors of patients. The short message-based customized standardized patient education program combines several smartphone message-based standardized educational contents to construct a customized patient education program which is according to the needs of patients, thus providing individualized patient education in a timely manner. The short message-based customized standardized patient education program may improve the diabetic foot ulcers self-management behavior and the self-efficacy on diabetic foot ulcers self-management, thereby promoting wound healing and improving quality of life.
The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.
The innovation of this study are as follows：our intervention is the first program in the world that (1) provides timely and individualized patient education in a customized standardized way, and (2) provides short message-based patient education for prevention and treatment of diabetic foot ulcers.
A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- customized standardized educational program sent by LINE software.
- Keywords
- short message, wound healing, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized standardized educational program sent by LINE software.Behavioural
At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object Receives: Behavioral: customized standardized educational program sent by LINE software. |
| comparison | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the Wound Shrinks
In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk.
Measured: baseline and after four, eight weeks
Diabetes-related Foot Ulcer Quality of Life
Questionnaire on quality of life with chronic wounds (Wound QoL-14) will be used at four weeks and eight weeks after baseline to evaluate the change of QOL. Questionnaire on quality of life with chronic wound (Wound-QoL) has 14 items to measure the quality of life of patients with chronic wounds. Using the 5-point Likert scale, the patients were asked to report their chronic wounds in the past seven days, ranging from 0 (not at all) to 4 (very affected), with higher average scores indicating poorer quality of life. The range of scores is 0 to 56.
Measured: Baseline and after four, eight weeks
Secondary outcomes (4)
Diabetes-related Foot Ulcer Self-management Behavior
In this study, "Diabetes-related Foot Ulcer Self-Management Behavior Scale" (DFUSMB), will be used to measure DFU self-management behavior at four weeks and eight weeks after baseline.
The DFUSMB measures behaviors that promote wound healing and prevent wound deterioration with 18 items in total, using the five-point Likert scale. "Never", "Seldom", "Sometimes", "Often" and "Always" are scored from 1 to 5 respectively. Reverse questions are scored in reverse, and the higher the total score, the better the self-management behavior of DFUs. In this study, we only collected the wound management subscale scores. The 7-item subscale score ranges 7-35. The DFUSMB has sufficient reliability and validity.
Measured: Baseline and after four, eight weeks
Diabtes-related Foot Ulcer Self-management Self-efficacy
We used 11 questions to measure the diabtes-related foot ulcer self-management self-efficacy, using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy. The sum score of the above 11 items indicates the DFU self-management self-efficacy with range from 0 to 110.
Measured: Baseline and after four, eight weeks
Diabetes Self-care Behaviors
The summary of diabetes self-care activity questionnaire (SDSCA) In this study, the summary of diabetes self-care activity questionnaire (SDSCA) will be used. The SDSCA questionnaire was developed by Deborah Toobert. It focuses on general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. The instrument assesses the absolute frequency or consistency of ten diabetes health-related regimen behaviors (e.g., number of days per week on which respondents engage in physical activity sessions; number of days in past 7 days respondents ate five or more servings of fruits and vegetables). Reverse questions are scored in reverse, and the higher the total score, the better the diabetes self-care activity. The total SDSCA score ranges 1-63.
Measured: Baseline and after four, eight weeks
Diabetes-related Foot Self-care Behavior
In this study, "Diabetic Foot Self-Care Behavior Scale" (DFSBS) will be used to measure diabetes-related foot self-care behavior at four weeks and eight weeks after baseline. The DFSBS has 7 questions, asking the participants how often they perform foot care behaviors. The total DFSBS score ranges 7-35. The higher the score, the better the foot care behavior. The DFSBS has sufficient reliability and validity.
Measured: Baseline and after four, eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start14 Sep 2023
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Why it stopped: Due to lack of funds and the lack of significant results from the pilot test, we terminated the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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
- Participants are assigned to two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin yenfan, Chang Gung Memorial Hospital
- Investigators
- Yenfan Chin, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037369
- Sponsor's protocol ID
- NMRPD1N0241
- Other IDs
- NSTC112-2314-B-182-028
- Status last verified
- Dec 2024
- First submitted
- 29 Aug 2023
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Short Message-based Customized Standardized Education Program in Promoting Wound Healing and Quality of Life of Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06037369
- Acronym / sponsor ID
- NMRPD1N0241
- Conditions
- Diabetic Foot Ulcer
- Keywords
- short message, wound healing, diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of funds and the lack of significant results from the pilot test, we terminated the study.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.
A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.
Detailed description
The diabetic foot ulcer need complex treatment, and is with poor prognosis, thus it consumes medical resources and impedes the quality of life of patients. Most of the time, patients are required to perform diabetic foot ulcer self-management at home. However, their self-management behaviors are inadequate.
Individualized patient education message can promote and maintain appropriate diabetes self-management behaviors of patients. The short message-based customized standardized patient education program combines several smartphone message-based standardized educational contents to construct a customized patient education program which is according to the needs of patients, thus providing individualized patient education in a timely manner. The short message-based customized standardized patient education program may improve the diabetic foot ulcers self-management behavior and the self-efficacy on diabetic foot ulcers self-management, thereby promoting wound healing and improving quality of life.
The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.
The innovation of this study are as follows：our intervention is the first program in the world that (1) provides timely and individualized patient education in a customized standardized way, and (2) provides short message-based patient education for prevention and treatment of diabetic foot ulcers.
A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: customized standardized educational program sent by LINE software.At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object |
| comparison | No intervention | –Routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| customized standardized educational program sent by LINE software.At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object. | Behavioural | intervention |
Primary outcome
Whether the Wound Shrinks
Time frame: baseline and after four, eight weeks
In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk.
Diabetes-related Foot Ulcer Quality of Life
Time frame: Baseline and after four, eight weeks
Questionnaire on quality of life with chronic wounds (Wound QoL-14) will be used at four weeks and eight weeks after baseline to evaluate the change of QOL. Questionnaire on quality of life with chronic wound (Wound-QoL) has 14 items to measure the quality of life of patients with chronic wounds. Using the 5-point Likert scale, the patients were asked to report their chronic wounds in the past seven days, ranging from 0 (not at all) to 4 (very affected), with higher average scores indicating poorer quality of life. The range of scores is 0 to 56.
4 secondary outcomes
Diabetes-related Foot Ulcer Self-management Behavior
Time frame: Baseline and after four, eight weeks
Diabtes-related Foot Ulcer Self-management Self-efficacy
Time frame: Baseline and after four, eight weeks
Diabetes Self-care Behaviors
Time frame: Baseline and after four, eight weeks
Diabetes-related Foot Self-care Behavior
Time frame: Baseline and after four, eight weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yenfan Chin principal investigator
Chang Gung 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 customized standardized educational program sent by LINE software. in people with Diabetic Foot Ulcer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 8 Jan 2025. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Whether the Wound Shrinks (time frame: baseline and after four, eight weeks). The study lists 2 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 8 Jan 2025.