Geko™ Cross Therapy Registry - Wound

NCT05007301 · tracked via the Priya Life Science UK tracker

Sponsor

Firstkind Ltd

Phase

Observational

Started

2022-04-04

Last updated

2026-09-15

Condition(s) studied

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

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
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

More Firstkind Ltd trials in the UK

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Other trials for the same condition

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Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers Starting soon

FeetSee Thermal Images Collection Protocol in Diabetes Patients Recruiting

The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study Active, not recruiting

Oasis Donor Site Wounds Post-Market Study Recruiting

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.

View NCT05007301 on ClinicalTrials.gov ↗ ← All trials in the UK