Efficacy Study for Geko Device in VLU Patients
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
1 other identifier
interventional
171
1 country
23
Brief 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 venous leg ulcers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2018
CompletedStudy Start
First participant enrolled
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2022
CompletedSeptember 21, 2023
September 1, 2023
4.1 years
September 12, 2017
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Linear healing rate (LHR)
Linear healing rate will be studied on a weekly basis
8 weeks
Secondary Outcomes (3)
Wound healing rate
Upto 8 weeks
Pain reduction
Upto 8 weeks
Change in Quality of Life
Upto 8 weeks
Study Arms (3)
Standard care alone (control)
NO INTERVENTIONMultilayer/multi component compression bandaging treatment
6 hours geko™ (no longer recruiting)
ACTIVE COMPARATORgeko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.
12 hours geko™
ACTIVE COMPARATORgeko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.
Interventions
The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Firstkind Ltdlead
Study Sites (23)
Trafalgar Group Medical Practice
Southsea, Portsmouth, PO5 3ND, United Kingdom
Crouch Oak Family Practice
Addlestone, KT15 2BH, United Kingdom
Barnsley Hospital NHS foundation Trust
Barnsley, S75 2EP, United Kingdom
Heart of Bath Medical Partnership
Bath, BA2 3HT, United Kingdom
West Walk Surgery
Bristol, BS37 4AX, United Kingdom
Rowden Surgery
Chippenham, SN15 2NB, United Kingdom
Lakeside Healthcare
Corby, NN17 2UR, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
South Tyneside NHS Foundation Trust
Hebburn, NE31 1AT, United Kingdom
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, PE30 4ET, United Kingdom
Lancashire Care NHS Trust
Leyland, PR25 2TN, United Kingdom
Accelerate CIC
London, E1 4DG, United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Central London Community Healthcare
London, W10 6DZ, United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich, NR2 3TU, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
The Adam Practice
Poole, BH16 5PW, United Kingdom
Hertfordshire Community NHS Trust
Stevenage, SG1 2UA, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Breckland Alliance
Thetford, IP24 2HY, United Kingdom
Welsh wound Innovation Centre
Wales, CF72 8UX, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1HN, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE, United Kingdom
Related Publications (2)
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.
PMID: 36785909RESULTBull 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.
PMID: 37526355RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Harding, FRCGP FRCP FRCS
Welsh Wound Innovation Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessors will be blinded to the study participants and what treatment they are receiving.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2017
First Posted
January 11, 2018
Study Start
April 24, 2018
Primary Completion
May 17, 2022
Study Completion
August 9, 2022
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share