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A Supportive Educative Health Promotion Intervention to Improve Self-Care Independence and Wound Healing in Patients with Diabetic Foot Ulcers

A Parallel-Group Randomized Controlled Trial Evaluating the Effectiveness of a Theory-Driven Supportive Educative Health Promotion Intervention on Self-Care Independence and Wound Healing Outcomes in Patients with Diabetic Foot Ulcers

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260302005
Enrollment
60
Registered
2026-03-02
Start date
2025-06-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer Diabetes Mellitus with Foot Complications Chronic Wound Diabetic foot ulcer randomized controlled trial self-care wound healing glycemic control health promotion

Interventions

Structured nurse-led home-based supportive educative program including behavioral activation, individualized goal setting, and self-care training for diabetic foot ulcer management, not a drug, not a
Experimental Behavioral,Experimental Behavioral
Supportive Educative Health Promotion Intervention,Standard Primary Care Wound Management

Sponsors

Faculty of Nursing, Universitas Airlangga, Surabaya, Indonesia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Diagnosed with diabetic foot ulcer grade 1 to 3 3. Receiving treatment at participating primary healthcare centers 4. Minimum one month of follow-up care 5. Able to communicate effectively 6. Willing to participate and provide written informed consent 7. No mental disorders

Exclusion criteria

Exclusion criteria: 1. Peripheral arterial disease requiring immediate surgical intervention 2, Severe cognitive impairment 3. Critical illness requiring hospitalization 4. Mental disorders

Design outcomes

Primary

MeasureTime frame
Independent Healthy Lifestyle Baseline (Week 0, pre-intervention) and Week 12 (post-intervention) Measured using a validated Likert-scale Healthy Lifestyle Behavior Questionnaire assessing diet adherence, blood glucose monitoring, and foot inspection. Higher scores indicate better adherence.

Secondary

MeasureTime frame
Wound Healing Baseline (Week 0, pre-intervention) and Week 12 (post-intervention) Bates Jensen Wound Assessment Tool BWAT score 13 to 65 lower score indicates better healing and random blood glucose measured by capillary blood test mg per dL

Countries

Indonesia

Contacts

Public ContactNovita MANALU

Universitas Airlangga

novita.verayanti.manalu-2022@fkp.unair.ac.id081368686004

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026