Venous Leg Ulcer (VLU)SMART-VLUNCT07163195
Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
A study testing Smart Bandage with Telemonitoring and Conventional Bandage in people with Venous Leg Ulcer (VLU) and Chronic Wound, run by Asmat Burhan at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Leg Ulcer (VLU), Chronic Wound
- What is being tested?
- Smart Bandage with Telemonitoring and Conventional Bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Jul 2026to 27 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Podiatry Clinic
Banyumas, Indonesia, 64118
Asmat Burhan, Master of Nursing Science, 085746157782, asmatburhan1@gmail.com
Indah Susanti, Master of Science Nursing, 085869181749, indahnoni138@gmail.com
About this study
Official title: Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
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.
Read the 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.
- Conditions
- Venous Leg Ulcer (VLU), Chronic Wound
- Being tested
- Smart Bandage with Telemonitoring, Conventional Bandage
- Keywords
- Venous Leg Ulcer, Chronic Wound, Smart Bandage, Telemonitoring, Digital Health, Mobile Application, Wound Care, Wound Healing, Randomized Controlled Trial, Indonesia
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Bandage with TelemonitoringDevice
Also called Smart wound bandage, Digital wound monitoring bandage
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 BandageDevice
Also called Standard wound dressing, Non-digital 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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Bandage + Standard Wound Care | Experimental | 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. Receives: Device: Smart Bandage with Telemonitoring |
| Conventional Bandage + Standard Wound Care | Active comparator | 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 Receives: Device: Conventional Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Secondary outcomes (3)
Percentage reduction in wound area
Change in ulcer size from baseline, measured using standardized digital photography and analyzed with ImageJ planimetry.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Health-related quality of life
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)
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Incidence of clinical infection
Presence of infection determined by clinical signs and classified according to the Society for Vascular Surgery WIfI system.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start26 Jul 2026 (estimated)
- Primary completion27 Dec 2026 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asmat Burhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asmat Burhan, Universitas Harapan Bangsa
- Investigators
- Septian Mixrova Sebayang, MSN, Principal investigator, Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163195
- Sponsor's protocol ID
- VLU-RCT-2025
- Other IDs
- B.LPPM.UHB/486/05/2025
- Acronym
- SMART-VLU
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial
- ClinicalTrials.gov ID
- NCT07163195
- Acronym / sponsor ID
- SMART-VLU / VLU-RCT-2025
- Conditions
- Venous Leg Ulcer (VLU), Chronic Wound
- Keywords
- Venous Leg Ulcer, Chronic Wound, Smart Bandage, Telemonitoring, Digital Health, Mobile Application, Wound Care, Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Asmat BurhanUniversity, hospital or other
- Study start
- 26 Jul 2026 (estimated)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smart Bandage + Standard Wound Care | Experimental | Device: Smart Bandage with TelemonitoringParticipants 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 comparator | Device: Conventional BandageParticipants 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 65 years
- Clinically diagnosed venous leg ulcer persisting for more than 3 weeks
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Bandage with TelemonitoringAlso: Smart wound bandage, Digital wound monitoring bandageA 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). | Device | Smart Bandage + Standard Wound Care |
| Conventional BandageAlso: Standard wound dressing, Non-digital bandageA 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. | Device | Conventional Bandage + Standard Wound Care |
Primary outcome
Proportion of ulcers achieving complete healing
Time frame: 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.
3 secondary outcomes
Percentage reduction in wound area
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Health-related quality of life
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Incidence of clinical infection
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Septian Mixrova Sebayang, MSN principal investigator
Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Bandage with Telemonitoring and Conventional Bandage in people with Venous Leg Ulcer (VLU) and Chronic Wound, run by Asmat Burhan at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Indah Susanti, MSN (+6285869181749, indahsusanti@uhb.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ulcers achieving complete healing (time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.