Geko™ Cross Therapy Registry - Wound

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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™

Conditions
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Wound, Venous Leg Ulcer, Diabetic Foot Ulcer, Arterial Leg Ulcer

Intervention / Treatment
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* Device: geko device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Patients who are receiving the geko device as part of standard of care for wound management | Device: geko device<br>* Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Up to 12 months from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geko, wound therapy, medical device, registry