Efficacy Study for Geko Device in VLU Patients (Canada)

Study Overview
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Brief Summary
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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
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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: A four-week Run-In Phase (day 0-28) A four-week Treatment Phase (day 28-56) 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

Official Title
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A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Participant Reported Outcomes, of Daily Geko™ Therapy in Conjunction With Standard Care to Standard Care Alone, in Patients With Venous Leg Ulcers

Conditions
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Venous Leg Ulcer, Leg Ulcer, Venous Ulcer

Intervention / Treatment
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* Device: geko


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years, able to provide written informed consent and comply with all study procedures and visit schedule Intact healthy skin at the site of geko™ device application. Have a (chronic) venous leg ulcer determined to be due to underlying venous disease following evaluation in a multi-professional setting or by a vascular surgeon, specialist physician or nurse wound specialist in accordance with Wounds Canada (2018), Health Quality Ontario Standards A VLU of approximately ≥ 5cm2 and ≤ 40cm2 at study enrolment i.e. Run in Phase Visit 1. If more than one ulcer is present, the largest ulcer within the given size range will be designated the study ulcer and the only one included in the study. If other ulcerations are present on the same leg, they must be more than 2 cm apart if they are two separate wounds. Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry. Ankle-Brachial Pressure Index (ABPI) of 0.8 -1.2 ± 0.05 inclusive (or equivalent measure) measured at study entry or within 12 weeks of study entry. No active local index wound infection for a minimum of 48 hours prior to study entry (RV1) No systemic antimicrobial treatment for a minimum of seven days prior to study entry (RV1) prescribed for index wound infection Must understand and is willing and able to participate in the study and to comply with all study procedures and study visit schedule Exclusion Criteria: Known allergy or intolerance to any of the protocol-stipulated treatments History of significant haematological disorders (e.g. Sickle Cell disease) History of Deep Vein Thrombosis (DVT) within six months preceding study entry History of Pyoderma Gangrenosum or other inflammatory ulceration BMI ≥ 40 Pregnancy or risk of pregnancy Use of investigational drug or device within four weeks prior to study entry that may interfere with the study Use of any neuro-modulation device Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement) Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. Implanted with a pacemaker or implantable cardioverter defibrillator (ICD). Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. higher dose systemic steroids). Participation in any other clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Multilayer, multicomponent compression intended for the treatment of VLU | |
| Active Comparator: Standard of care + geko 12h<br>Multilayer multicomponent compression intended for the treatment of VLU in conjuction with geko™ therapy 12 hours daily | Device: geko<br>* The geko device will be self-administered and deliver 12 hours of therapy daily.<br>* Other names: geko 12h;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geko, compression bandaging, wound, ulcer