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Active, Not Recruiting

NCT Number: NCT05007301

Geko™ Cross Therapy Registry - Wound

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central London Community Health Care NHS Trust, London, United Kingdom

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

geko device

Device

Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Official study 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™

Acronym: CTR-Wound

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Aug 16, 2021
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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