A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer

NCT06540170 | Completed Results

• 1 other identifier: 2022/00895
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Ulcer

Keywords

Diabetic foot ulcer; self-care support; Motivational interviewing

Outcome Measures

Primary Outcomes (2)

• 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.

  4 weeks post-intervention from baseline.

• Acceptability of the Intervention

  Participants will be interviewed to determine the acceptability of the intervention.

  4 weeks post-intervention from baseline.

Secondary Outcomes (8)

• Patients' Adherence to Foot Self-care Behaviour

  4 weeks post-intervention from baseline.

• Patients' Foot Care Confidence (Self-efficacy)

  4 weeks post-intervention from baseline.

• Patients' Illness Belief

  4 weeks post-intervention from baseline.

• Patients' Perceptions of Autonomy Support

  4 weeks post-intervention from baseline.

• Patients' Diabetes Distress

  4 weeks post-intervention from baseline.

Study Arms (1)

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.

Behavioral: A personalised self-care support program

Interventions

A personalised self-care support program BEHAVIORAL

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.

Single arm

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Healthcare Group Polyclinics: lead
• Nanyang Technological University: collaborator

Study Sites (1)

National Healthcare Group Polyclinics

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 41062140 DERIVED

MeSH Terms

Conditions

Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Senior Wound Nurse Clinician
• Organization: National Healthcare Group Polyclinics

julia_zhu@nhgp.com.sg

64966611

Study Officials

• Julia Xiaoli Zhu

  National Healthcare Group Polyclinics Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Nurse Clinician Wound Management

Model Details: Single-group pre-intervention and post-intervention comparison

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 6, 2024
• Study Start: August 13, 2024
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)