Efficacy Study for Geko Device in VLU Patients (Canada)
NCT05057793 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2024-03-01
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.
Conditions
- Venous Leg Ulcer
- Leg Ulcer
- Venous Ulcer
Interventions
- DEVICE
-
geko
The geko device will be self-administered and deliver 12 hours of therapy daily.
Sponsors & Collaborators
-
Firstkind Ltd
lead INDUSTRY
Principal Investigators
-
Garry Sibbald · University of Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-22
- Primary Completion
- 2022-09-23
- Completion
- 2022-09-23
Countries
- Canada
Study Locations
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