WoundCTR-WoundNCT05007301
Geko™ Cross Therapy Registry - Wound
An observational study of Wound and Venous Leg Ulcer, run by Firstkind Ltd at 3 sites in 2 countries.
Trial summary
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- What is being tested?
- geko device
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Apr 2022to Mar 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged ≥ 18 years
- Intact healthy skin at the site of geko™ device application.
- Willing and able to give written informed consent
- Presence of an ulcerative wound to the lower leg
- Identified to receive geko™ therapy as part of their standard care for wound management.
Who cannot join
- Pregnancy or breast feeding.
- Use of any other neuro-modulation device.
- Current use of TENS in the pelvic region, back or legs
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Central London Community Health Care NHS Trust
London, W10 6DZ
Norfolk Community Health and Care NHS Trust
Norwich, NR2 3TU
About this study
Official title: Geko™ Cross Therapy Registry - Wound An Observational Study for the Post Market Clinical Follow-up of Safety and Patient Outcomes for Patients Undergoing Peroneal Nerve Stimulation by Geko™
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.
Read the detailed description
The geko™ Cross Therapy REGISTRY - Wound represents a long-term project to integrate prospectively and systematically collected clinical data on all geko™ W wound devices (or W device variants) used in SC pathways for wound management allowing for the monitoring of patient outcomes during a follow-up period of up to four follow-up visits.
The clinical database collected for the geko™ CTR - Wound will form part of the overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. There will be up to 50 contributing centres globally. Participants are asked at the time of signing up for the geko™ Cross Therapy REGISTRY - Wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).
- Conditions
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
- Being tested
- geko device
- Keywords
- geko, wound therapy, medical device, registry
- Medical subject headings
- Wounds and Injuries, Varicose Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko deviceDevice
Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Patients who are receiving the geko device as part of standard of care for wound management Receives: Device: geko device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Obtain frequency of adverse events (AEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Measured: Up to 12 months from study entry
Frequency of serious adverse events
Obtain frequency of serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Measured: Up to 12 months from study entry
Frequency of device deficiencies
Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Measured: Up to 12 months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start4 Apr 2022
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnes Collarte, Principal investigator, Central London Community Health Care NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007301
- Sponsor's protocol ID
- FSK-REG-002
- Acronym
- CTR-Wound
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geko™ Cross Therapy Registry - Wound An Observational Study for the Post Market Clinical Follow-up of Safety and Patient Outcomes for Patients Undergoing Peroneal Nerve Stimulation by Geko™
- ClinicalTrials.gov ID
- NCT05007301
- Acronym / sponsor ID
- CTR-Wound / FSK-REG-002
- Conditions
- Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
- Keywords
- geko, wound therapy, medical device, registry
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Aug 2021 (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.
The geko™ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.
Detailed description
The geko™ Cross Therapy REGISTRY - Wound represents a long-term project to integrate prospectively and systematically collected clinical data on all geko™ W wound devices (or W device variants) used in SC pathways for wound management allowing for the monitoring of patient outcomes during a follow-up period of up to four follow-up visits.
The clinical database collected for the geko™ CTR - Wound will form part of the overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. There will be up to 50 contributing centres globally. Participants are asked at the time of signing up for the geko™ Cross Therapy REGISTRY - Wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | Device: geko devicePatients who are receiving the geko device as part of standard of care for wound management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Aged ≥ 18 years
- Intact healthy skin at the site of geko™ device application.
- Willing and able to give written informed consent
- Presence of an ulcerative wound to the lower leg
- Identified to receive geko™ therapy as part of their standard care for wound management.
Key exclusion criteria (5 listed)
- Pregnancy or breast feeding.
- Use of any other neuro-modulation device.
- Current use of TENS in the pelvic region, back or legs
- Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
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 |
|---|---|---|
| geko deviceNeuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks. | Device | Standard of care |
Primary outcome
Frequency of adverse events
Time frame: Up to 12 months from study entry
Obtain frequency of adverse events (AEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Frequency of serious adverse events
Time frame: Up to 12 months from study entry
Obtain frequency of serious AEs (SAEs) whether device related or not and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
Frequency of device deficiencies
Time frame: Up to 12 months from study entry
Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., geko™ therapy vs standard care without geko™ therapy
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Agnes Collarte principal investigator
Central London Community Health Care NHS Trust
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound and Venous Leg Ulcer, run by Firstkind Ltd at 3 sites in 2 countries.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (time frame: Up to 12 months from study entry). The study lists 3 primary outcomes in all. 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 15 Sep 2026.