Clinical trial NCT05007301: Geko™ Cross Therapy Registry - Wound
Official 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™
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Wound
Venous Leg Ulcer
Diabetic Foot Ulcer
Arterial Leg Ulcer
Keywords: geko
wound therapy
medical device
registry
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will have been identified to receive geko™ therapy as part of their standard care for wound management. All participants must be at least 18 years of age and must be able to provide written informed consent.

Brief 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.

Detailed description: 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).

Eligibility criteria: 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 outcomes:
measure: Frequency of adverse events
timeFrame: Up to 12 months from study entry
measure: Frequency of serious adverse events
timeFrame: Up to 12 months from study entry
measure: Frequency of device deficiencies
timeFrame: Up to 12 months from study entry
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell Health System
state: New York
city: London
country: United Kingdom
facility: Central London Community Health Care NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
Study officials:
affiliation: Central London Community Health Care NHS Trust
name: Agnes Collarte
role: PRINCIPAL_INVESTIGATOR
References: