Zapping a leg nerve: can a wearable device help stubborn ulcers heal?

NCT ID NCT05007301

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Apr 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Diabetic Foot injury ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Central London Community Health Care NHS Trust

    London, W10 6DZ, United Kingdom

  • Norfolk Community Health and Care NHS Trust

    Norwich, NR2 3TU, United Kingdom

  • Northwell Health System

    New York, New York, 11042, United States

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