Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 7:07 AM
Study NCT ID:
NCT05057793
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study for Geko Device in VLU Patients (Canada)
Sponsor:
Firstkind Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: