N/A
Completed N=29
A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer
Foot Ulcer
Source: ClinicalTrials.gov NCT06540170 ↗
Enrolled (actual)
29
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Feasibility of Recruiting and Retaining — 26 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruiting and Retaining |
26 | — |
| PRIMARY Acceptability of the Intervention |
26 | — |
| SECONDARY Patients' Adherence to Foot Self-care Behaviour |
20.2 | — |
| SECONDARY Patients' Foot Care Confidence (Self-efficacy) |
32.7 | — |
| SECONDARY Patients' Illness Belief |
47.9 | — |
| SECONDARY Patients' Perceptions of Autonomy Support |
3.5 | — |
| SECONDARY Patients' Diabetes Distress |
3.5 | — |
| SECONDARY Patients' Knowledge of Recognizing Wound Deterioration |
7.7 | — |
| SECONDARY Patients' Quality of Life |
57.3 | — |
| SECONDARY HbA1c |
83 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06540170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.