WoundVenous Leg UlcerDiabetic Foot UlcerArterial Leg Ulcer
Investigational drug(s) / intervention(s)
geko device
geko device: Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aged ≥ 18 years
2. Intact healthy skin at the site of geko™ device application.
3. Willing and able to give written informed consent
4. Presence of an ulcerative wound to the lower leg
5. Identified to receive geko™ therapy as part of their standard care for wound management.
Exclusion Criteria:
1. Pregnancy or breast feeding.
2. Use of any other neuro-modulation device.
3. Current use of TENS in the pelvic region, back or legs
4. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
5. No response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
Primary outcome measure(s)
Frequency of adverse events — 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 — 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 — 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
Trial sites (3)
Facility
City
Region
Status
Northwell Health System
New York
New York
Central London Community Health Care NHS Trust
London
United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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