Geko™ Cross Therapy Registry - Wound (CTR-Wound)

  • End date
    Mar 19, 2028
  • participants needed
  • sponsor
    Firstkind Ltd
Updated on 4 October 2022
wound care
wound treatment


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).

Condition Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer
Treatment geko device
Clinical Study IdentifierNCT05007301
SponsorFirstkind Ltd
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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