Chronic Wound, Venous Leg Ulcer (VLU)
Conditions
Keywords
Venous Leg Ulcer, Chronic Wound, Smart Bandage, Telemonitoring, Digital Health, Mobile Application, Wound Care, Wound Healing, Randomized Controlled Trial, Indonesia
Brief summary
Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new "smart bandage" that can monitor wound conditions such as pH, temperature, and moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time. The purpose of this randomized controlled trial is to compare smart bandage plus standard wound care with standard wound care alone. We will assess whether the smart bandage improves healing rates within 12 weeks, shortens time to healing, reduces infection, and improves quality of life in patients with VLUs. About 110 adult participants with VLUs will be enrolled at Clinic Podiatry Care, Purwokerto, Indonesia.
Detailed description
Venous leg ulcers (VLUs) are chronic wounds with significant clinical and economic burden. Healing is often delayed due to persistent inflammation, tissue hypoxia, and susceptibility to infection. Smart bandage technologies offer a novel approach by integrating sensors that can continuously monitor wound conditions (pH, temperature, moisture) and transmit data via a mobile application for real-time telemonitoring. This enables wound care providers to adjust treatment promptly and may improve patient engagement and outcomes. This randomized controlled trial will compare smart bandage plus standard wound care with standard wound care alone in adult patients with VLUs. The intervention group will receive a smart bandage with pH, temperature, and moisture sensors connected to a secure mobile app monitored by wound care nurses. The control group will receive standard care including compression therapy, conventional dressings, debridement as indicated, and patient education. The primary outcome is the proportion of ulcers achieving complete healing within 12 weeks, defined as full epithelialization without drainage. Secondary outcomes include time to healing, percentage wound area reduction (measured by digital planimetry), incidence of clinical infection, and health-related quality of life (Wound-QoL questionnaire). A total of 110 participants will be recruited at Clinic Podiatry Care, Purwokerto, Indonesia. Randomization will be performed in a 1:1 ratio using computer-generated block randomization. Outcome assessors and data analysts will be blinded. Analyses will follow the intention-to-treat principle, with χ² tests for primary outcomes and generalized estimating equations for repeated measures. The study is designed to provide robust clinical evidence on the effectiveness of smart bandage technology combined with telemonitoring in VLU care, with the potential to inform integration of digital wound care into clinical practice.
Interventions
DEVICESmart Bandage with Telemonitoring
A smart wound bandage with integrated sensors (pH, temperature, moisture) connected to a mobile telemonitoring platform. Wound data are transmitted securely to a mobile application monitored by wound care nurses. The device is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education).
DEVICEConventional Bandage
A conventional wound bandage without digital monitoring features. It is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education). This represents usual care according to international guidelines.
Sponsors
Asmat Burhan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors who evaluate digital wound images and statistical analysts will be blinded to treatment allocation. Participants, care providers, and investigators will not be masked.
Intervention model description
Participants will be randomized in a 1:1 ratio to either the intervention group (smart bandage plus standard wound care) or the control group (standard wound care alone). Both groups will be followed for 12 weeks in parallel. Randomization will use computer-generated block randomization with allocation concealment. Outcome assessors and data analysts will be blinded to group assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 65 years * Clinically diagnosed venous leg ulcer persisting for more than 3 weeks * Able to provide written informed consent
Exclusion criteria
* Age \>65 years (elderly patients excluded) * Acute or emergency wounds * Mixed etiology ulcers with significant arterial involvement * Severe comorbid illness such as end-stage renal failure or active malignancy * Cognitive impairment preventing informed consent * Allergy to dressing materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of ulcers achieving complete healing | Baseline, 4 weeks, 8 weeks, and 12 weeks | Complete healing is defined as full epithelialization of the ulcer without drainage, confirmed at two consecutive visits by wound care nurses using standardized clinical assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in wound area | Baseline, 4 weeks, 8 weeks, and 12 weeks | Change in ulcer size from baseline, measured using standardized digital photography and analyzed with ImageJ planimetry. |
| Health-related quality of life | Baseline, 4 weeks, 8 weeks, and 12 weeks | Wound Quality of Life questionnaire (Wound-QoL-17). Report global score and three subscales: Body/Physical, Psyche/Psychological, Everyday life. Scores are calculated as the mean item on a scale of 0-4; range 0-4, and higher scores = poorer quality of life (greater impairment). Reported as change from baseline at each time point. Unit of Measure: points (0-4) |
| Incidence of clinical infection | Baseline, 4 weeks, 8 weeks, and 12 weeks | Presence of infection determined by clinical signs and classified according to the Society for Vascular Surgery WIfI system. |
Countries
Indonesia
Contacts
CONTACTIndah Susanti, MSN
CONTACTDiaz Ibrahim, MSN
PRINCIPAL_INVESTIGATORSeptian Mixrova Sebayang, MSN
Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto
Outcome results
None listed