Venous Leg UlcerNCT05057793
Efficacy Study for Geko Device in VLU Patients (Canada)
A study testing geko in people with Venous Leg Ulcer and Leg Ulcer, run by Firstkind Ltd at 3 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- What is being tested?
- geko
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesCanada
- Study dates
- 22 Aug 2022to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Mayer Institute
Hamilton, ONL8R2R3
Vascular Health Bronte
Oakville, ONL6M4J2
Care Partners (Waterloo)
Waterloo, ONN2L6H7
About this study
Official title: 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
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.
Read the detailed 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:
- 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
- Conditions
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- Being tested
- geko
- Keywords
- geko, compression bandaging, wound, ulcer
- Medical subject headings
- Varicose Ulcer, Leg Ulcer, Wounds and Injuries, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gekoDevice
Also called NMES, geko device, geko 12h
The geko device will be self-administered and deliver 12 hours of therapy daily.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Multilayer, multicomponent compression intended for the treatment of VLU |
| Standard of care + geko 12h | Active comparator | Multilayer multicomponent compression intended for the treatment of VLU in conjuction with geko™ therapy 12 hours daily Receives: Device: geko |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start22 Aug 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Why it stopped: Difficulties with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garry Sibbald, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057793
- Sponsor's protocol ID
- FSK-VLU-006
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05057793
- Acronym / sponsor ID
- FSK-VLU-006
- Conditions
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- Keywords
- geko, compression bandaging, wound, ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Multilayer, multicomponent compression intended for the treatment of VLU |
| Standard of care + geko 12h | Active comparator | Device: gekoMultilayer multicomponent compression intended for the treatment of VLU in conjuction with geko™ therapy 12 hours daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gekoAlso: NMES, geko device, geko 12hThe geko device will be self-administered and deliver 12 hours of therapy daily. | Device | Standard of care + geko 12h |
Primary outcome
Change in linear healing rate in the treatment phase compared to the run-in phase
Time frame: 8 weeks
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).
4 secondary outcomes
Weekly change in linear healing rate
Time frame: 8 weeks
Change in pain score using the VAS (Visual Analogue Scale)
Time frame: 8 weeks
Change in quality of life using the EQ-5D-5L (health-related quality of life measure) questionnaire
Time frame: 8 weeks
Change in quality of life using the CWIS (Cardiff Wound Impact Schedule)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Device official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry Sibbald principal investigator
University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko in people with Venous Leg Ulcer and Leg Ulcer, run by Firstkind Ltd at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in linear healing rate in the treatment phase compared to the run-in phase (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.