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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05057793
Study type Interventional
Source Firstkind Ltd
Contact Marie-Therese Targett
Phone +44 (0) 7340 903 377
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 2021
Completion date December 2022

See also
  Status Clinical Trial Phase
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Not yet recruiting NCT04078555 - A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer Phase 2