Venous Leg UlcerNCT03396731
Efficacy Study for Geko Device in VLU Patients
A study testing geko™ medical device in people with Venous Leg Ulcer and Leg Ulcers Venous, run by Firstkind Ltd at 23 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer
- What is being tested?
- geko™ medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 23 sitesUnited Kingdom
- Study dates
- 24 Apr 2018to 9 Aug 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
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United Kingdom23 sites
Crouch Oak Family Practice
Addlestone, KT15 2BH
Barnsley Hospital NHS foundation Trust
Barnsley, S75 2EP
Heart of Bath Medical Partnership
Bath, BA2 3HT
West Walk Surgery
Bristol, BS37 4AX
Rowden Surgery
Chippenham, SN15 2NB
Lakeside Healthcare
Corby, NN17 2UR
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW
South Tyneside NHS Foundation Trust
Hebburn, NE31 1AT
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, PE30 4ET
Lancashire Care NHS Trust
Leyland, PR25 2TN
Accelerate CIC
London, E1 4DG
Royal Free London NHS Foundation Trust
London, NW3 2QG
Central London Community Healthcare
London, W10 6DZ
Norfolk Community Health and Care NHS Trust
Norwich, NR2 3TU
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
The Adam Practice
Poole, BH16 5PW
Trafalgar Group Medical Practice
Southsea, Portsmouth, PO5 3ND
Hertfordshire Community NHS Trust
Stevenage, SG1 2UA
Musgrove Park Hospital
Taunton, TA1 5DA
Breckland Alliance
Thetford, IP24 2HY
Welsh wound Innovation Centre
Wales, CF72 8UX
Worcestershire Royal Hospital
Worcester, WR5 1HN
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE
About this study
Official title: 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
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
Read the detailed description
- 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
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg, Wound
- Being tested
- geko™ medical device
- Keywords
- VLU, Venous Leg Ulcer, Leg Ulcer, Leg Wound
- Medical subject headings
- Varicose Ulcer, Leg Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™ medical deviceDevice
The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
| Study group | Role | What they receive |
|---|---|---|
| Standard care alone (control) | No intervention | Multilayer/multi component compression bandaging treatment |
| 6 hours geko™ (no longer recruiting) | Active comparator | geko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. Receives: Device: geko™ medical device |
| 12 hours geko™ | Active comparator | geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. Receives: Device: geko™ medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear healing rate (LHR)
Linear healing rate will be studied on a weekly basis
Measured: 8 weeks
Secondary outcomes (3)
Wound healing rate
Measured with the images taken
Measured: Upto 8 weeks
Pain reduction
Participant reported outcome of pain reduction using Visual Analogue Scale (VAS)
Measured: Upto 8 weeks
Change in Quality of Life
Change in Quality of Life based on participant reported outcomes using EQ-5D-5L questionnaire
Measured: Upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start24 Apr 2018
- Primary completion17 May 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, FRCGP FRCP FRCS, Principal investigator, Welsh Wound Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396731
- Sponsor's protocol ID
- FSK-VLU-004
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2017
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bull RH, Clements D, Collarte AJ, Harding KG. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J. 2023 Aug;20(6):2260-2268. doi: 10.1111/iwj.14107. Epub 2023 Feb 13.
PubMed 36785909Bull RH, Clements D, Collarte AJ, Harding KG. A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions. Adv Wound Care (New Rochelle). 2023 Dec;12(12):671-679. doi: 10.1089/wound.2023.0058. Epub 2023 Sep 5.
PubMed 37526355
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. 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 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
- ClinicalTrials.gov ID
- NCT03396731
- Acronym / sponsor ID
- FSK-VLU-004
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg, Wound
- Keywords
- VLU, Venous Leg Ulcer, Leg Ulcer, Leg Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 11 Jan 2018 (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.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care alone (control) | No intervention | –Multilayer/multi component compression bandaging treatment |
| 6 hours geko™ (no longer recruiting) | Active comparator | Device: geko™ medical devicegeko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. |
| 12 hours geko™ | Active comparator | Device: geko™ medical devicegeko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| geko™ medical deviceThe geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device. | Device | 12 hours geko™, 6 hours geko™ (no longer recruiting) |
Primary outcome
Linear healing rate (LHR)
Time frame: 8 weeks
Linear healing rate will be studied on a weekly basis
3 secondary outcomes
Wound healing rate
Time frame: Upto 8 weeks
Pain reduction
Time frame: Upto 8 weeks
Change in Quality of Life
Time frame: Upto 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Results publication: PubMed 36785909Bull RH, Clements D, Collarte AJ, Harding KG. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J. 2023 Aug;20(6):2260-2268. doi: 10.1111/iwj.14107. Epub 2023 Feb 13.
- Results publication: PubMed 37526355Bull RH, Clements D, Collarte AJ, Harding KG. A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions. Adv Wound Care (New Rochelle). 2023 Dec;12(12):671-679. doi: 10.1089/wound.2023.0058. Epub 2023 Sep 5.
- Device official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Venous Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
Not yet recruitingPhase 2
Controlled Study, Performed to Evaluate the Safety and Efficacy of EscharEx and Its Placebo (Gel Vehicle) Compared to Non-surgical Standard of Care in Participants With Venous Leg Ulcers (VLU)
Venus Leg Ulcers
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Venous Leg Ulcer (VLU)
Not yet recruitingPhase 1/2
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
Lower Extremity, Chronic Ulcers
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.
Keith Harding, FRCGP FRCP FRCS principal investigator
Welsh Wound Innovation Centre
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko™ medical device in people with Venous Leg Ulcer and Leg Ulcers Venous, run by Firstkind Ltd at 23 sites in United Kingdom.
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 11 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Linear healing rate (LHR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396731, which also lists 2 linked publications.
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 21 Sep 2023.