Efficacy Study for Geko Device in VLU Patients

Study Overview
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Brief Summary
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Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase). To compare two daily geko™ device treatment durations, six hours and 12 hours, in conjunction with SC, with each other and to SC alone, in patients with venous leg ulcers

Detailed Description
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Screen patient database to identify eligible patients Obtain informed consent and inform participant's GP Complete CRF throughout the study period (demographics, vital signs, medical history, study ulcer history, concomitant medication) Physical examination at the study start up visit and at consecutive weekly visits Take a digital image of the wound at participants weekly visits Assess and report adverse events Apply standard care (compression bandaging) at weekly visits and record all the dressing usage Perform randomisation at the end of week 4 and allocate participant to one of the three treatment groups. Train the participant to use gekoTM devices Schedule weekly visits

Official Title
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A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy, Including Patient Reported Outcomes of Two Different Daily gekoTM Treatment Durations in Conjunction With Standard Care, With Each Other and to Standard Care Alone, in Patients With Venous Leg Ulcers

Conditions
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Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg, Wound

Intervention / Treatment
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* Device: geko™ medical device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization. Male or female aged ≥ 18 years and able to provide written informed consent. Intact healthy skin at the site of gekoTM device application. Patients who have a chronic venous leg ulcer determined to be due to underlying venous disease following evaluation in a multidisciplinary clinic setting. A VLU of approximately ≥ 3cm2 and ≤ 39 cm2 at study enrolment i.e. Run In Phase Visit 1 (RV1). 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 have to be more than 2 cm apart if they are 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 (i.e. RV1). Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry (i.e. RV1). No active local or systemic infection for a minimum of 48 hours prior to study entry (i.e. RV1). No systemic antimicrobial treatment for a minimum of seven days prior to study entry prescribed for index wound infection (i.e. RV1). Patient understands and is willing to participate in the study and is able to comply with study procedures and visits. Note: At the randomisation visit, the study ulcer needs to be ≥ 2 cm2 and ≤ 30 cm2. Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomisation: Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy. History of significant haematological disorders (e.g. Sickle Cell disease). History of Deep Vein Thrombosis (DVT) within six months preceding study entry (i.e. RV1). History of Pyoderma Gangrenosum or other inflammatory ulceration. Pregnancy or breast feeding. Use of investigational drug or device within four weeks prior to study entry (i.e. RV1) that may interfere with this study. Use of any neuro-modulation device. Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement) (i.e. RV1). Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. No involuntary movement of the lower leg/foot at the maximum tolerable device setting. Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. 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 care alone (control)<br>Multilayer/multi component compression bandaging treatment | |
| Active Comparator: 6 hours geko™ (no longer recruiting)<br>geko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. | Device: geko™ medical device<br>* The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.<br>|
| Active Comparator: 12 hours geko™<br>geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. | Device: geko™ medical device<br>* The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear healing rate (LHR) | Linear healing rate will be studied on a weekly basis | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing rate | Measured with the images taken | Upto 8 weeks | 
| Pain reduction | Participant reported outcome of pain reduction using Visual Analogue Scale (VAS) | Upto 8 weeks | 
| Change in Quality of Life | Change in Quality of Life based on participant reported outcomes using EQ-5D-5L questionnaire | Upto 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLU, Venous Leg Ulcer, Leg Ulcer, Leg Wound