Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
171 participants
INTERVENTIONAL
2018-04-24
2022-08-09
Brief Summary
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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
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Detailed Description
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2. Obtain informed consent and inform participant's GP
3. Complete CRF throughout the study period (demographics, vital signs, medical history, study ulcer history, concomitant medication)
4. Physical examination at the study start up visit and at consecutive weekly visits
5. Take a digital image of the wound at participants weekly visits
6. Assess and report adverse events
7. Apply standard care (compression bandaging) at weekly visits and record all the dressing usage
8. Perform randomisation at the end of week 4 and allocate participant to one of the three treatment groups.
9. Train the participant to use gekoTM devices
10. Schedule weekly visits
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard care alone (control)
Multilayer/multi component compression bandaging treatment
No interventions assigned to this group
6 hours geko™ (no longer recruiting)
geko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.
geko™ medical device
The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
12 hours geko™
geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.
geko™ medical device
The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
Interventions
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geko™ medical device
The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
Eligibility Criteria
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Inclusion Criteria
1. Male or female aged ≥ 18 years and able to provide written informed consent.
2. Intact healthy skin at the site of gekoTM device application.
3. Patients who have a chronic venous leg ulcer determined to be due to underlying venous disease following evaluation in a multidisciplinary clinic setting.
4. 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.
5. 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).
6. 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).
7. No active local or systemic infection for a minimum of 48 hours prior to study entry (i.e. RV1).
8. No systemic antimicrobial treatment for a minimum of seven days prior to study entry prescribed for index wound infection (i.e. RV1).
9. 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
1. Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy.
2. History of significant haematological disorders (e.g. Sickle Cell disease).
3. History of Deep Vein Thrombosis (DVT) within six months preceding study entry (i.e. RV1).
4. History of Pyoderma Gangrenosum or other inflammatory ulceration.
5. Pregnancy or breast feeding.
6. Use of investigational drug or device within four weeks prior to study entry (i.e. RV1) that may interfere with this study.
7. Use of any neuro-modulation device.
8. Surgery during three months prior to study entry (such as abdominal, gynaecological, hip or knee replacement) (i.e. RV1).
9. Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
10. No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
11. Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids).
12. Participation in any other clinical study.
18 Years
ALL
No
Sponsors
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Firstkind Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Keith Harding, FRCGP FRCP FRCS
Role: PRINCIPAL_INVESTIGATOR
Welsh Wound Innovation Centre
Locations
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Trafalgar Group Medical Practice
Southsea, Portsmouth, United Kingdom
Crouch Oak Family Practice
Addlestone, , United Kingdom
Barnsley Hospital NHS foundation Trust
Barnsley, , United Kingdom
Heart of Bath Medical Partnership
Bath, , United Kingdom
West Walk Surgery
Bristol, , United Kingdom
Rowden Surgery
Chippenham, , United Kingdom
Lakeside Healthcare
Corby, , United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, , United Kingdom
South Tyneside NHS Foundation Trust
Hebburn, , United Kingdom
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, , United Kingdom
Lancashire Care NHS Trust
Leyland, , United Kingdom
Accelerate CIC
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Central London Community Healthcare
London, , United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
The Adam Practice
Poole, , United Kingdom
Hertfordshire Community NHS Trust
Stevenage, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Breckland Alliance
Thetford, , United Kingdom
Welsh wound Innovation Centre
Wales, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
York Teaching Hospital NHS Foundation Trust
York, , United Kingdom
Countries
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References
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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.
Bull 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Device official website
Publication- International Wound Journal
Other Identifiers
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FSK-VLU-004
Identifier Type: -
Identifier Source: org_study_id
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