Foot UlcerNCT06540170
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
A study testing A personalised self-care support program in people with Foot Ulcer, run by National Healthcare Group Polyclinics at 1 site in Singapore.
Trial summary
This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses, and is feasible to deliver supportive self-care for primary care patients living… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Foot Ulcer
- What is being tested?
- A personalised self-care support program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Aug 2024to 11 Jan 2025
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes and DFU aged 21 years or above receiving treatment and wound care at National Healthcare Group Polyclinics
- HCPs, who are aged 21 years or above with a patient-facing role working in delivering program (only for qualitative interviews)
Who cannot join
- Patients have a diagnosis of critical lower limb ischemia, active osteomyelitis, Charcot foot, cognitive/psychiatric diagnoses, and hearing or vision impairment.
- Pregnant women will be excluded from the study for both patient and HCP groups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses, and is feasible to deliver supportive self-care for primary care patients living with DFU.
The main questions it aims to answer are:
Read more
- Is the personalized self-care improvement program acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses to deliver?
- Is the personalized self-care improvement program feasible for supportive self-care for primary care patients living with DFU? Researchers will compare pre-intervention to post-intervention to see if the personalized self-care improvement program works to support self-care management for patients with DFU.
Participants will:
-receive three 30-minute face-to-face intervention sessions every 2 weeks within 6 weeks after their routine wound care dressing.
Read the detailed description
This study aims to assess the potential benefit(s) of a personalized intervention integrating motivational interviewing (MI) with positive psychological skills for supportive self-care among patients with diabetic foot ulcers.
A single-arm pilot feasibility study using a mixed-method approach will be conducted between Aug 2024 and February 2025. 30 participants will be recruited from nurse-led wound clinics in a large primary care sector and selected according to the inclusion criteria. Participants will receive three 30-minute face-to-face sessions of an MI-based personalized care program over 6 weeks to support DFU self-care coping behaviors.
The primary outcomes include the feasibility of recruitment and the acceptability of the proposed personalized intervention. Feasibility will be assessed based on recruitment and 4 weeks retention of participants from last intervention session through examination of screening logs and follow-up completion. Acceptability to patients and healthcare professionals (HCPs) will be evaluated using semi-structured individual interviews.
The secondary outcomes include patient-reported outcome measures (PROM) consisting of DFU self-care behaviors, self-efficacy, psychological determinants, and clinical endpoints such as foot skin conditions and glycemic control (measured by HbA1C). The results will be evaluated by comparing baseline and post-intervention data collected at week 0 and week 4 from last intervention session, for any differences in PROMs and clinical outcomes. Differences in PROMs between the two time points will be assessed using univariable analyses such as the chi-square test for categorical variables and independent samples t-test or analysis of variance (ANOVA) for continuous variables where appropriate.
Semi-structured face-to-face individual qualitative interviews will be conducted at the end of the pilot trial to provide insight into peoples' experiences of participation in the intervention. Data will be analyzed thematically.
- Conditions
- Foot Ulcer
- Being tested
- A personalised self-care support program
- Keywords
- Diabetic foot ulcer, self-care support, Motivational interviewing
- Medical subject headings
- Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A personalised self-care support programBehavioural
A personalized care program consists of three 30-minute face-to-face sessions (once every 2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Eligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 2 weeks) within 6 weeks of enrolment. Receives: Behavioral: A personalised self-care support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruiting and Retaining
The number of patients recruited to the study and retained at the end of the study period will be documented.
Measured: 4 weeks post-intervention from baseline.
Acceptability of the Intervention
Participants will be interviewed to determine the acceptability of the intervention.
Measured: 4 weeks post-intervention from baseline.
Secondary outcomes (8)
Patients' Adherence to Foot Self-care Behaviour
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Foot Care Confidence (Self-efficacy)
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Illness Belief
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Perceptions of Autonomy Support
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Diabetes Distress
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Knowledge of Recognizing Wound Deterioration
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.
Measured: 4 weeks post-intervention from baseline.
Patients' Quality of Life
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.
Measured: 4 weeks post-intervention from baseline.
HbA1c
HbA1c for participants who have completed the program.
Measured: 4 weeks post-intervention from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start13 Aug 2024
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group pre-intervention and post-intervention comparison
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group Polyclinics
- Sponsor type
- Other government
- Collaborators
- Nanyang Technological University
- Responsible party
- Principal investigator, Julia Zhu Xiaoli, National Healthcare Group Polyclinics
- Investigators
- Julia Xiaoli Zhu, Principal investigator, National Healthcare Group Polyclinics Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540170
- Sponsor's protocol ID
- 2022/00895
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2024
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Lee ES, Chan FHF, Yin R, Lim PXH, Koh RWS, Judith C, Wei L, Li S, Phrommarad P, Chin GHY, Lim VH, Low RSY, Chen YC, Griva K. Feasibility and acceptability of a personalised self-care support programme for primary care patients with diabetic foot ulcers delivered by wound care nurses: the HEALing study protocol. BMJ Open. 2025 Oct 7;15(10):e098024. doi: 10.1136/bmjopen-2024-098024.
PubMed 41062140
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06540170
- Acronym / sponsor ID
- 2022/00895
- Conditions
- Foot Ulcer
- Keywords
- Diabetic foot ulcer, self-care support, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Healthcare Group PolyclinicsOther government
- Collaborators
- Nanyang Technological University
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to learn if a personalized self-care program supporting self-care and Healing through Empowerment and Active Listening (HEALing), is acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses, and is feasible to deliver supportive self-care for primary care patients living with DFU.
The main questions it aims to answer are:
- Is the personalized self-care improvement program acceptable to patients with diabetic foot ulcer (DFU) and wound care nurses to deliver?
- Is the personalized self-care improvement program feasible for supportive self-care for primary care patients living with DFU? Researchers will compare pre-intervention to post-intervention to see if the personalized self-care improvement program works to support self-care management for patients with DFU.
Participants will:
-receive three 30-minute face-to-face intervention sessions every 2 weeks within 6 weeks after their routine wound care dressing.
Detailed description
This study aims to assess the potential benefit(s) of a personalized intervention integrating motivational interviewing (MI) with positive psychological skills for supportive self-care among patients with diabetic foot ulcers.
A single-arm pilot feasibility study using a mixed-method approach will be conducted between Aug 2024 and February 2025. 30 participants will be recruited from nurse-led wound clinics in a large primary care sector and selected according to the inclusion criteria. Participants will receive three 30-minute face-to-face sessions of an MI-based personalized care program over 6 weeks to support DFU self-care coping behaviors.
The primary outcomes include the feasibility of recruitment and the acceptability of the proposed personalized intervention. Feasibility will be assessed based on recruitment and 4 weeks retention of participants from last intervention session through examination of screening logs and follow-up completion. Acceptability to patients and healthcare professionals (HCPs) will be evaluated using semi-structured individual interviews.
The secondary outcomes include patient-reported outcome measures (PROM) consisting of DFU self-care behaviors, self-efficacy, psychological determinants, and clinical endpoints such as foot skin conditions and glycemic control (measured by HbA1C). The results will be evaluated by comparing baseline and post-intervention data collected at week 0 and week 4 from last intervention session, for any differences in PROMs and clinical outcomes. Differences in PROMs between the two time points will be assessed using univariable analyses such as the chi-square test for categorical variables and independent samples t-test or analysis of variance (ANOVA) for continuous variables where appropriate.
Semi-structured face-to-face individual qualitative interviews will be conducted at the end of the pilot trial to provide insight into peoples' experiences of participation in the intervention. Data will be analyzed thematically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group pre-intervention and post-intervention comparison
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Behavioral: A personalised self-care support programEligible and willing participants will be invited to participate in the program and receive three 30-minute face-to-face sessions (once every 2 weeks) within 6 weeks of enrolment. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diabetes and DFU aged 21 years or above receiving treatment and wound care at National Healthcare Group Polyclinics
- HCPs, who are aged 21 years or above with a patient-facing role working in delivering program (only for qualitative interviews)
Key exclusion criteria (2 listed)
- Patients have a diagnosis of critical lower limb ischemia, active osteomyelitis, Charcot foot, cognitive/psychiatric diagnoses, and hearing or vision impairment.
- Pregnant women will be excluded from the study for both patient and HCP groups
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 |
|---|---|---|
| A personalised self-care support programA personalized care program consists of three 30-minute face-to-face sessions (once every 2 weeks) after patients' routine wound dressings to enhance self-efficacy, support emotional adjustments, and DFU self-care. | Behavioural | Single arm |
Primary outcome
Feasibility of Recruiting and Retaining
Time frame: 4 weeks post-intervention from baseline.
The number of patients recruited to the study and retained at the end of the study period will be documented.
Acceptability of the Intervention
Time frame: 4 weeks post-intervention from baseline.
Participants will be interviewed to determine the acceptability of the intervention.
8 secondary outcomes
Patients' Adherence to Foot Self-care Behaviour
Time frame: 4 weeks post-intervention from baseline.
Patients' Foot Care Confidence (Self-efficacy)
Time frame: 4 weeks post-intervention from baseline.
Patients' Illness Belief
Time frame: 4 weeks post-intervention from baseline.
Patients' Perceptions of Autonomy Support
Time frame: 4 weeks post-intervention from baseline.
Patients' Diabetes Distress
Time frame: 4 weeks post-intervention from baseline.
Patients' Knowledge of Recognizing Wound Deterioration
Time frame: 4 weeks post-intervention from baseline.
Patients' Quality of Life
Time frame: 4 weeks post-intervention from baseline.
HbA1c
Time frame: 4 weeks post-intervention from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41062140Zhu X, Lee ES, Chan FHF, Yin R, Lim PXH, Koh RWS, Judith C, Wei L, Li S, Phrommarad P, Chin GHY, Lim VH, Low RSY, Chen YC, Griva K. Feasibility and acceptability of a personalised self-care support programme for primary care patients with diabetic foot ulcers delivered by wound care nurses: the HEALing study protocol. BMJ Open. 2025 Oct 7;15(10):e098024. doi: 10.1136/bmjopen-2024-098024.
- Individual participant dataSharing planned: No
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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.
Julia Xiaoli Zhu principal investigator
National Healthcare Group Polyclinics Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A personalised self-care support program in people with Foot Ulcer, run by National Healthcare Group Polyclinics at 1 site in Singapore.
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 2 inclusion and 2 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 26 Aug 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 Singapore. 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 26 Aug 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?
Feasibility of Recruiting and Retaining (time frame: 4 weeks post-intervention from baseline.). 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?
On the ClinicalTrials.gov record for NCT06540170, which also lists 1 linked publication.
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 26 Aug 2025.