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
Phase: NA
Conditions: Diabetic Foot Ulcer
Sponsor: Chang Gung Memorial Hospital

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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 
NCT06037369 
Unique Protocol ID: NMRPD1N0241 
Second ID: NSTC112-2314-B-182-028 
The protocol was approved by the Chang Gung Medical Foundation 
Institutional Review Board on February 17, 2023 
IRB No. 202202161B0 
 
 
 
Principal Investigator: Yen-Fan Chin  
Date: 2023. 8.30 
 
 
 

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INTRODUCTION 
Diabetic foot ulcers need complex treatment and have poor prognoses. 
Thus, they consume medical resources and impede patients' quality of life. 
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 messages can promote and maintain 
appropriate diabetes self-management behaviors. The short 
message-based customized standardized patient education program 
combines several smartphone message-based standardized educational 
contents to construct a customized patient education program that is 
according to patients' needs, thus promptly providing individualized 
patient education. The short message-based customized standardized 
patient education program may improve diabetic foot ulcer 
self-management behavior and self-efficacy on diabetic foot ulcer 
self-management, thereby promoting wound healing and improving 
quality of life. 
This study aims to develop a short, message-based, customized 
standardized 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. 
2. METHODS 
2.1 Study design 
A customized standardized patient education module will be developed 
and evaluated. A randomized controlled study design will be adopted. 

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Participants will be assigned to two parallel groups for the duration of the 
study. 
2.2 Study setting and participants 
The participants will be recruited from August 2023 to July 2026 and 
followed up for eight weeks at a medical center in northern Taiwan. 
Recruited criteria were: (1) outpatients with DFUs over 20 years old; (2) 
can be interviewed in Mandarin or Taiwanese. 
The exclusion criteria were: patients (1) planning to return visits 
within eight weeks less than two times; (2) without using a smartphone; 
(3) being unable to read text messages on a mobile phone or with 
impaired hearing; (4) with impaired fine hand movements; (5) unwilling 
to use the communication software LINE to receive text messages. 
2.3 Sample size and statistical power 
In this study, we will use the generalized estimating equation (GEE) to 
detect the effectiveness of intervention in improving the quality of life. 
Since no previous research results are available for reference, we assume 
that the intervention in this study has a moderate effect. We set the effect 
amount as 0.25, the statistical power as 0.95, the alpha value as 0.05, and 
the number of repeated measurements as 3. The G*power 3.1 statistical 
software shows that the required sample size was 178.  
2.4 Intervention group 
At each visit of the research subjects to the plastic clinic, the research 
team records the attending prescriptions and patient education given by 
the medical team members and evaluates whether the research subjects 
and caregivers need additional mental support. Then, according to the 

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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 period proposed by the 
research subject 
2.5 Control group 
Subjects will receive routine care. 
2.6 Measurements 
2.6.1 Sociodemographic and clinical information 
This study collected data by foot assessment, medical record review, and 
questionnaire interviews.  
2.6.2 Whether the Wound Shrinks 
This study will measure the wound size at baseline, four and eight weeks. 
Then, whether the wound has shrunk will be determined by subtracting 
the pre-measurement area from the post-measurement area. 
2.6.3 Diabetes-related Foot Ulcer Quality of Life  
A questionnaire on quality of life with chronic wounds (Wound QoL-14) 
will be used to evaluate the change in QOL. The questionnaire on quality 
of life with chronic wounds (Wound-QoL) has 14 items to measure 
patients' quality of life with chronic wounds. Using the 5-point Likert 
scale, the influence of chronic wounds in the past seven days ranges from 
0 (not at all) to 4 (significantly affected), with higher scores indicating 
poorer quality of life. The range of scores is 0 to 56. 
2.6.4 Diabetes-related foot ulcer self-management behavior  
In this study, Chin et al. (2019) used the Diabetes-related Foot Ulcer 
Self-Management Behavior Scale (DFUSMB) to measure DFU 

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self-management behavior. 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. The higher the total score, the better the 
self-management behavior. The DFUSMB has sufficient reliability and 
validity (Chin et al., 2019).  
2.6.5 Diabetes-related Foot Ulcer Self-management Self-efficacy  
We used 11 questions to measure the diabetes-related foot ulcer 
self-management self-efficacy, using an 11-point scale, with 0 indicating 
no confidence and 10 indicating complete confidence. The high scores 
reflect high self-efficacy. The sum score of the above 11 items indicates 
the DFU self-management self-efficacy with a range from 0 to 110. 
2.6.6 Diabetes-related foot self-care behavior  
This study used Chin & Huang's (2013) Diabetes-related Foot Self-Care 
Behavior Scale (DFSBS) to measure participants' diabetes-related 
foot-care behavior. The DFSBS has seven questions measuring the 
frequency of foot care behaviors delivery. The higher the score, the better 
the foot care behavior. The DFSBS has sufficient reliability and validity 
(Chin & Huang, 2013).  
2.6.7 Diabetes self-care behaviors  
In this study, the summary of the diabetes self-care activity questionnaire 
(SDSCA) will be used. Deborah Toobert developed the SDSCA 
questionnaire. It focuses on general diet, diabetes-specific diet, physical 
activity, blood-glucose testing, foot care, and smoking. The instrument 

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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 the 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 from 1-63. 
2.7 Data collection 
Before the study delivery, we will perform block randomization of four 
categories according to the statistical software (Sealed Envelope Ltd., 
2022), with four as the block, and create label categories and case 
acceptance order according to the software allocation group, then putting 
the group name into the envelope. This study adopted categorical random 
allocation, with four categories: patients with neuropathic foot ulcers who 
received hemodialysis, patients with neuropathic foot ulcers who did not 
receive hemodialysis, patients without neuropathic foot ulcers who 
received hemodialysis, patients without neuropathic foot ulcers who did 
not receive hemodialysis. 
After the research subjects agree to participate, the project leader 
will open envelopes to arrange their group location. Then, the data 
collection begins, including basic information on the research subjects, 
self-care behavior for diabetes, foot, and diabetic foot ulcers, self-efficacy 
in preventing and treating foot ulcers, quality of life, and wound 
measurement. Two post-tests (questionnaire interview and wound 

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assessment) will be conducted four and eight weeks after baseline data 
collection. 
2.8 Data analysis 
The data will be analyzed with SPSS statistical software for Windows 
20.0 (SPSS, Inc., Chicago, IL, USA). The chi-square and Mann-Whitney 
U tests will be used to determine the homogeneity between the 
intervention and control groups. An intention-to-treat analysis approach 
(ITT) will be used. Generalized estimating equations (GEEs) will be used 
to examine the effects of intervention measures on improving the study 
subjects' self-care behavior, self-efficacy, and quality of life. The 
chi-square test will be used to detect whether there was any difference in 
the proportion of wounds reduced by 50% or more between the two 
groups of study subjects four weeks after admission.