Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Proportion of ulcers achieving complete healing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years
- •Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
- •Able to provide written informed consent
排除标准
- •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
研究组 & 干预措施
Smart Bandage + Standard Wound Care
Participants in this arm will receive a smart bandage with integrated sensors (pH, temperature, and moisture) connected to a mobile telemonitoring platform. Wound data will be transmitted securely to wound care nurses for review. In addition, patients will receive standard wound care including compression therapy, conventional dressings, sharp debridement when indicated, and patient education.
干预措施: Smart Bandage with Telemonitoring (Device)
Conventional Bandage + Standard Wound Care
Participants will receive standard wound care (compression therapy, debridement when indicated, and patient education) plus a conventional bandage without digital monitoring features. This represents usual care according to international guidelines
干预措施: Conventional Bandage (Device)
结局指标
主要结局
Proportion of ulcers achieving complete healing
时间窗: 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.
次要结局
- Percentage reduction in wound area(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Health-related quality of life(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Incidence of clinical infection(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Percentage reduction in wound area(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Health-related quality of life(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Incidence of clinical infection(Baseline, 4 weeks, 8 weeks, and 12 weeks)
研究者
Asmat Burhan
Lecturer/Researcher, Faculty of Health Sciences, Universitas Harapan Bangsa
Universitas Harapan Bangsa