Geko™ Cross Therapy Registry - Wound

Running, not enrolling

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

In brief

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.

Key facts

Study ID

NCT05007301

Run by

Firstkind Ltd

People needed

2500

Starts

2022-04-04

Expected to finish

2028-03-01

Last updated by the study team

2024-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Northwell Health System — New York, New York, United States
• Central London Community Health Care NHS Trust — London, United Kingdom
• Norfolk Community Health and Care NHS Trust — Norwich, United Kingdom

Full record on ClinicalTrials.gov

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