Clinical Trials Logo

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
Recruiting NCT03903692 - A Comparative Evaluation of a MPS Dressing and a CMC Dressing on Subjects With Lower Extremity Venous Ulcers N/A
Completed NCT03257254 - Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Recruiting NCT03666754 - Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer N/A
Not yet recruiting NCT05007301 - Geko™ Cross Therapy Registry - Wound
Withdrawn NCT02912858 - Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients N/A
Completed NCT02482038 - Geko Venous Leg Ulcer Study N/A
Completed NCT02652572 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Venous Leg Ulcers Phase 1
Unknown status NCT01658618 - Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer N/A
Completed NCT03077165 - Dose-response Relationship Study of S42909 on Leg Ulcer Healing Phase 2
Completed NCT04461132 - The Effect of Manual Lymphatic Drainage N/A
Recruiting NCT04011371 - Cyanoacrylate Closure for Treatment of Venous Leg Ulcers N/A
Not yet recruiting NCT03543007 - Evaluating the Safety and Efficacy of GrafixPL™PRIME for the Treatment of Chronic Venous Leg Ulcers N/A
Completed NCT03286140 - Early Venous Reflux Ablation Ulcer Trial N/A
Not yet recruiting NCT04613687 - Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of VLU (FREEDOM) N/A
Not yet recruiting NCT03670329 - Management of Infection Risk in Non-comparative Trial (MINT) N/A
Completed NCT02921750 - Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin N/A
Completed NCT03021811 - EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management N/A
Terminated NCT01817543 - A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers N/A
Completed NCT01153633 - Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel Phase 4
Not yet recruiting NCT04078555 - A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer Phase 2