Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
SMART-VLU
Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
2 other identifiers
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJanuary 12, 2026
January 1, 2026
3 months
August 31, 2025
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of ulcers achieving complete healing
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary Outcomes (3)
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
Study Arms (2)
Smart Bandage + Standard Wound Care
EXPERIMENTALParticipants 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.
Conventional Bandage + Standard Wound Care
ACTIVE COMPARATORParticipants 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
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Adults aged 18 to 65 years
- Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
- Able to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asmat Burhanlead
Study Sites (1)
Podiatry Clinic
Banyumas, Indonesia, 64118, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Septian Mixrova Sebayang, MSN
Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer/Researcher, Faculty of Health Sciences, Universitas Harapan Bangsa
Study Record Dates
First Submitted
August 31, 2025
First Posted
September 9, 2025
Study Start
February 1, 2026
Primary Completion
April 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- De-identified IPD and supporting information (study protocol, SAP, and analytic code) will be available beginning 6 months after publication of the main trial results and will remain available for 3 years thereafter.
- Access Criteria
- De-identified individual participant data (IPD) and supporting information (study protocol, SAP, and analytic code) will be made available to qualified researchers with methodologically sound proposals. Data will be provided for use in research consistent with the original trial objectives. Requests should be directed to the Principal Investigator via email. Access will be granted after review of the proposal and signing of a data sharing agreement.
De-identified individual participant data (IPD) for primary and secondary outcomes, including baseline demographics, ulcer characteristics, intervention assignment, and outcome data. Time Frame: Available starting 6 months after publication of the main results, for up to 3 years. Access Criteria: Available to qualified researchers with sound proposals consistent with the study objectives. Access Method: By request to the Principal Investigator via email; access requires a data sharing agreement.