NCT05057793

Efficacy Study for Geko Device in VLU Patients (Canada)

A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Participant Reported Outcomes, of Daily Geko™ Therapy in Conjunction With Standard Care to Standard Care Alone, in Patients With Venous Leg Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Firstkind Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go through a four-week run-in phase, followed by a four-week treatment phase and a three-month long term follow-up.

Detailed description

This study is designed to evaluate the efficacy of geko™ therapy for 12 hours daily in conjunction with Standard Care (SC), consisting of multilayer, multicomponent compression therapy intended for the treatment of VLUs, compared to SC alone in participants with VLUs. The study will be a multicentre study with study centres in Ontario Canada. The study will have three phases: 1. A four-week Run-In Phase (day 0-28) 2. A four-week Treatment Phase (day 28-56) 3. A long term Follow-Up Phase (day 84, 112 \& 140 after EOT) During the Run-In Phase all participants will receive SC only and will be evaluated on a weekly basis (day 0, 7, 14 \& 21). On day 28, once the Investigator has confirmed the participant's continued eligibility, randomization and assignment to study treatment will take place. During the long term follow-up phase, participants continue with their assigned study treatment and will be seen and evaluated on day 84, 112 and 140

Conditions

• Venous Leg Ulcer
• Leg Ulcer
• Venous Ulcer

Interventions

Type	Name	Description
DEVICE	geko	The geko device will be self-administered and deliver 12 hours of therapy daily.

Timeline

• Start date: 2022-08-22
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2021-09-27
• Last updated: 2024-03-01

Locations

3 sites across 1 country: Canada