Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial

Официальное название

Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Smart 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).
• Устройство Conventional 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.

Первичные конечные точки

• Proportion of ulcers achieving complete healing [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]

Вторичные конечные точки (3)

• Percentage reduction in wound area [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Health-related quality of life [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Incidence of clinical infection [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]

Критерии участия

Критерии включения

• Adults aged 18 to 65 years
• Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
• Able to provide written informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Podiatry Clinic — Banyumas

Идентификаторы

NCT: NCT07163195 · VLU-RCT-2025 · B.LPPM.UHB/486/05/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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