NCT05007301

Geko™ Cross Therapy Registry - Wound

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™

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Firstkind Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Wound
• Venous Leg Ulcer
• Diabetic Foot Ulcer
• Arterial Leg Ulcer

Interventions

Type	Name	Description
DEVICE	geko device	Neuromuscular electrostimulation of the peroneal nerve, 12h per day, for up to 12 weeks.

Timeline

• Start date: 2022-04-04
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2021-08-16
• Last updated: 2024-03-01

Locations

3 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study