An observational study in Wound, Venous Leg Ulcer and Diabetic Foot Ulcer, sponsored by Firstkind Ltd. Active, not recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Firstkind Ltd (part of Sky Medical Technology) · Observational
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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.
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).
2,217 studies on the registry are indexed under Wounds and Injuries; 440 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Firstkind Ltd is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are receiving the geko device as part of standard of care for wound management
Device: geko device
Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.
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
Time frame: 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
Time frame: 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
Time frame: Up to 12 months from study entry
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Sep 2027, 65 months after the start.
Of 47 industry-sponsored observational studies under Wounds and Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 63. This study's planned 65 months is above that.
Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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