Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05057793
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
Study:
NCT05057793
Study Brief:
Protocol Section:
NCT05057793