The Short Message-based Customized Standardized

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037369
• Other study ID #: NMRPD1N0241
• Secondary ID: NSTC112-2314-B-1
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Yenfan Chin
• Phone: 032118800
• Email: yenfan[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Description:

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 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. In the first year, a customized standardized patient education program will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and 178 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 generalized estimating equation (GEE) will be used to evaluate the effectiveness of the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	In this study, whether the percentage foot ulcer area reduction (PAR) reaches 50% after four weeks and whether DFU is healed is used as the evaluation index. We used the following formula to calculate the percentage area reduction (PAR): PAR = (primary wound area - secondary area / primary area) × 100	baseline and after four and eight weeks
Primary	DFU Quality of life	Questionnaire on quality of life with chronic wounds (Wound QoL-17) 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 17 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 total DFUSMB score ranges 0-68.	Baseline and after four and eight weeks
Secondary	DFU self-management behavior	In this study, "DFU 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. The total DFUSMB score ranges 18-90.The DFUSMB has sufficient reliability and validity.	Baseline and after four and eight weeks
Secondary	DFU self-management self-efficacy	The researcher developed the Diabetic Foot Ulcer Self-Efficacy Scale (DFUMSE) consisting of 17 self-constructed questions to measure self-efficacy in diabetic foot ulcer management. A scoring system of 0 to 10 points is used, where 0 points indicate no confidence at all, and 10 points indicate complete confidence. Higher scores indicate higher self-efficacy. The total DFUMSE score ranges 0-170.; Two questions were used to measure self-efficacy for foot self-care: "I am confident that I can: Check the soles and toe gaps of my feet every day by myself (or with someone's assistance)." "I am confident that I can: Apply lotion or Vaseline to my feet every day by myself (or with someone's assistance) when the skin on my feet is dry." Both questions were scored using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy.	Baseline and after four and eight weeks
Secondary	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 eleventh question asks whether there is smoking, and if so, it is counted as 1 point. The total SDSCA score ranges 1-71.	Baseline and after four and eight weeks
Secondary	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.	Baseline and after four and eight weeks