Zapping a leg nerve: can a wearable device help stubborn ulcers heal?
NCT ID NCT05007301
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are collecting real-world data on the geko device, a small wearable that stimulates the peroneal nerve in the leg, for people with lower-leg ulcers. The registry follows about 2,500 adults who use the device as part of their standard wound care for up to 12 weeks. It tracks adverse events, serious adverse events, and device problems to see how the device performs outside a controlled trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- geko device, a small wearable that electrically stimulates the peroneal nerve in the leg
- What this could lead to
- If the device helps, it could offer a drug-free way to support healing for people with venous, diabetic, or arterial leg ulcers.
- What could go wrong
- This is an observational registry, not a controlled trial, so it cannot prove the device causes better healing. Results may be limited by missing data and differences between patients.
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.
- Participants
-
About 2,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Mar 2028
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.
Who is studied
Participants will have been identified to receive geko™ therapy as part of their standard care for wound management. All participants must be at least 18 years of age and must be able to provide written informed consent.
- 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: 1. Aged ≥ 18 years 2. Intact healthy skin at the site of geko™ device application. 3. Willing and able to give written informed consent 4. Presence of an ulcerative wound to the lower leg 5. Identified to receive geko™ therapy as part of their standard care for wound management. Exclusion Criteria: 1. Pregnancy or breast feeding. 2. Use of any other neuro-modulation device. 3. Current use of TENS in the pelvic region, back or legs 4. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. 5. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
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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.
Contacts and locations
Locations
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Central London Community Health Care NHS Trust
London, W10 6DZ, United Kingdom
-
Norfolk Community Health and Care NHS Trust
Norwich, NR2 3TU, United Kingdom
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Northwell Health System
New York, New York, 11042, United States
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