Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
NCT ID: NCT07163195
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2026-02-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
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
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.
Interventions
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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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
* Able to provide written informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Asmat Burhan
OTHER
Responsible Party
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Asmat Burhan
Lecturer/Researcher, Faculty of Health Sciences, Universitas Harapan Bangsa
Principal Investigators
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Septian Mixrova Sebayang, MSN
Role: PRINCIPAL_INVESTIGATOR
Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto
Locations
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Podiatry Clinic
Banyumas, Indonesia, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Study Documents
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Document Type: Individual Participant Data Set
The de-identified IPD underlying primary and secondary outcomes, along with the study protocol and SAP, will be available upon reasonable request to the Principal Investigator via email. Access requires a data sharing agreement.
View DocumentDocument Type: Statistical Analysis Plan
The statistical analysis plan (SAP) describes predefined methods for analyzing the primary and secondary outcomes, including sample size justification, handling of missing data, and statistical tests. Available upon request to the PI
View DocumentDocument Type: Analytic Code
Analytic code used for data processing and statistical analyses, including scripts for wound area measurement (ImageJ) and outcome analyses (SPSS/R). The code will be available by request to the PI and requires a data sharing agreement
View DocumentRelated Links
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Official study information page hosted by Klinik Podiatry Care, Purwokerto
Other Identifiers
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B.LPPM.UHB/486/05/2025
Identifier Type: OTHER
Identifier Source: secondary_id
VLU-RCT-2025
Identifier Type: -
Identifier Source: org_study_id
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