Trial Outcomes & Findings for A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer (NCT NCT06540170)
NCT ID: NCT06540170
Last Updated: 2025-08-26
Results Overview
The number of patients recruited to the study and retained at the end of the study period will be documented.
COMPLETED
NA
29 participants
4 weeks post-intervention from baseline.
2025-08-26
Participant Flow
Participant milestones
| Measure |
Single Arm Study
Single-arm study: pre- and post-intervention
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
Baseline characteristics by cohort
| Measure |
Single Arm Study
n=26 Participants
Single-arm study: pre- and post-intervention
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: 3 patients withdrew from the study due to changes to their healthcare institutions (e.g., from primary care settings to secondary/tertiary settings).
The number of patients recruited to the study and retained at the end of the study period will be documented.
Outcome measures
| Measure |
Single Arm
n=29 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Feasibility of Recruiting and Retaining
|
26 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary clinics
Participants will be interviewed to determine the acceptability of the intervention.
Outcome measures
| Measure |
Single Arm
n=29 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Acceptability of the Intervention
|
26 Participants
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using the 7-item Diabetes Foot Self-Care Behavior Scale. All items on the scale are rated on a 5-point Likert-type scale. The higher scores represent better foot self-care behaviors. The minimum value is 7 and the maximum is 35.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Adherence to Foot Self-care Behaviour
|
20.2 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using the 12-item Foot Care Confidence Scale. All items on the scale are rated on a 5-point Likert-type scale. The higher scores represent better foot care confidence. The minimum value is 12 and the maximum value is 60.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Foot Care Confidence (Self-efficacy)
|
32.7 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using the 8-item Brief Illness Perception Questionnaire, each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all eight items where items 3, 4, and 7 are inversed. The possible range of scores is 0 (minimum value)-80 (maximum value). Higher scores indicate worse illness perception.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Illness Belief
|
47.9 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using the 6-item Health Care Climate Questionnaire that patients rate items on a 7-point Likert scale (1 = not at all true, 7 = very true). The minimum value is 1 and the maximum value is 7. The higher score represents greater autonomy support.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Perceptions of Autonomy Support
|
3.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using Diabetes Distress Scale consists of 17 items with four subscales including emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. All items were rated on a 6-point Likert scale. The minimum value is 1 and the maximum value is 6. The higher score indicates greater distress.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Diabetes Distress
|
3.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using Warning Signs of Diabetic Foot Ulcer Deterioration Questionnaire comprising of 12 items. Each item with the correct answer obtains a score of 1. The minimum score is 0 and the maximum value is 12. The higher scores represent better knowledge.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Knowledge of Recognizing Wound Deterioration
|
7.7 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with diabetic foot ulcers receiving wound care at the participating primary care clinics (excluding 3 withdrawals due to changes to primary care institutions)
Measured using EQ-5D-5L that is self-reported by patients and consists of two parts: a descriptive system and a visual analogue scale. The visual analogue scale for imaginative health state is used for the pilot study. The minimum value is 0 and the maximum value is 100. The higher score represents the better 0 imaginative health state.
Outcome measures
| Measure |
Single Arm
n=26 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
Patients' Quality of Life
|
57.3 units on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 4 weeks post-intervention from baseline.Population: Participants with an active DFU receiving wound care at the participating clinics
HbA1c for participants who have completed the program.
Outcome measures
| Measure |
Single Arm
n=19 Participants
Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 1-2 weeks) within 3-6 weeks of enrolment.
A personalised self-care support program: A personalized care program consists of three 30-minute face-to-face sessions (once every 1-2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
|
|---|---|
|
HbA1c
|
83 mmol/mol
Standard Deviation 42
|
Adverse Events
Single Arm Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Wound Nurse Clinician
National Healthcare Group Polyclinics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place