Smart bandage could track wound healing without peeking
NCT ID NCT05805137
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new system that uses a special bandage with electrodes to monitor how well venous leg ulcers are healing. The system measures electrical signals through the wound and sends data to a phone app. Twenty adults with chronic leg ulcers will be monitored up to three times a week until the wound heals or for two months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a more accurate, easy way to track wound healing without removing dressings.
- What could go wrong
- This is a small, early-stage study focused on monitoring, not treatment. The device may not prove reliable or practical in real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age at least 18 years * The subject has a chronic lower extremity ulcer with a primary etiology of venous insufficiency. The previous venous procedure is not an obstacle to the study * Compression therapy can be implemented * The wound is not wider than 5 cm and the electrode dressing can be placed on the wound as intended. The wound should be located above the ankle, on the skin area where the electrode dressing can be placed properly. * The wound is not deep with steep edges or cavity-like * The wound is not highly excreting * The wound can be expected to heal within two months (area reduced ≥ 90% from baseline) * The subject gives consent to the study and commits to following the instructions of the medical staff Exclusion Criteria: * Clinical wound infection at the time of the study * The subject has an intravenous (in Tampere: A venous operation) procedure within 2 months * Significant arterial circulatory disorder or adherence problem that prevents compression therapy (in Tampere: Contraindication for compression therapy, e.g. significant arterial circulatory disorder or severe heart failure) * Subject movement 2-3 times a week during the study to the study site is difficult to arrange (in Tampere: Subject not able to commit to study visits 2-3 times a week.) * Diagnosed epoxy resin allergy * Any other reasons of potential study subject non-compliance by the opinion of the investigator Additional local exclusion criteria in Tampere site: * Special groups, such as pregnant women/patients trying to conceive during the study or patients with reduced autonomy * Subject with any implantable electrical device. Such as pacemaker or implanted defibrillator. Patient has other electrically conductive implanted material in legs. Such as a metallic prostheses.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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TAYS Haavakeskuksen poliklinikka
RECRUITINGTampere, 33520, Finland
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University Clinical Centre, Gdańsk
RECRUITINGGdansk, Poland
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