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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
The geko device will be self-administered and deliver 12 hours of therapy daily.
The Mayer Institute
Hamilton, Canada
Vascular Health Bronte
Oakville, Canada
Care Partners (Waterloo)
Waterloo, Canada
Change in linear healing rate in the treatment phase compared to the run-in phase
The pair-wise comparison of linear healing rate (wound margin advance, WMA) during Treatment Phase compared with WMA from the Run-in Phase both the treatment arm (SC plus 12 hours daily treatment with the geko™ W device or variant) and control arm (SC only).
Time frame: 8 weeks
Weekly change in linear healing rate
Weekly wound margin advance of the study ulcer measured by an independent blinded wound expert using digital images taken at each weekly visit until end of treatment.
Time frame: 8 weeks
Change in pain score using the VAS (Visual Analogue Scale)
Patient will indicate their pain score at each weekly visit using a visual analogue scale (VAS), with 0 being no pain at all and 100 being worst pain imaginable (measured in mm)
Time frame: 8 weeks
Change in quality of life using the EQ-5D-5L (health-related quality of life measure) questionnaire
EQ-5D-5L a descriptive system for health-related quality of life (HRQoL) states in adults, consisting of five dimensions (mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression). Participant will complete questionnaire at the beginning of the run in phase, at randomization and at the end of treatment. Each level is scored ona 5 level severity ranking, with 1 being no problems, to 5 being extreme problems.
Time frame: 8 weeks
Change in quality of life using the CWIS (Cardiff Wound Impact Schedule)
Cardiff Wound Impact Schedule (CWIS) is used to measure the impact of chronic wounds (leg ulcers and diabetic foot ulcers) on HRQoL and identify areas of participant concern. The questionnaire will be completed by the participant at the beginning of the run in phase, at randomization and at the end of treatment. The overall score will be between 0 and 100, with a higher score indicating a better quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 8 weeks