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

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

Study Overview

• Status: Completed
• Conditions: Leg Ulcer; Venous Leg Ulcer; Wound; Wound Leg; Leg Ulcers Venous
• Intervention / Treatment: Device: geko™ medical device

Detailed Description

1. Screen patient database to identify eligible patients
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

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Addlestone, United Kingdom, KT15 2BH
    • Crouch Oak Family Practice
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley Hospital NHS Foundation Trust
  • Bath, United Kingdom, BA2 3HT
    • Heart of Bath Medical Partnership
  • Bristol, United Kingdom, BS37 4AX
    • West Walk Surgery
  • Chippenham, United Kingdom, SN15 2NB
    • Rowden Surgery
  • Corby, United Kingdom, NN17 2UR
    • Lakeside Healthcare
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter NHS Foundation Trust
  • Hebburn, United Kingdom, NE31 1AT
    • South Tyneside NHS Foundation Trust
  • Kings Lynn, United Kingdom, PE30 4ET
    • The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
  • Leyland, United Kingdom, PR25 2TN
    • Lancashire Care NHS Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free London NHS Foundation Trust
  • London, United Kingdom, E1 4DG
    • Accelerate CIC
  • London, United Kingdom, W10 6DZ
    • Central London Community Healthcare
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital
  • Norwich, United Kingdom, NR2 3TU
    • Norfolk Community Health and Care NHS Trust
  • Poole, United Kingdom, BH16 5PW
    • The Adam Practice
  • Stevenage, United Kingdom, SG1 2UA
    • Hertfordshire Community NHS Trust
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
  • Thetford, United Kingdom, IP24 2HY
    • Breckland Alliance
  • Wales, United Kingdom, CF72 8UX
    • Welsh wound Innovation Centre
  • Worcester, United Kingdom, WR5 1HN
    • Worcestershire Royal Hospital
  • York, United Kingdom, YO31 8HE
    • York Teaching Hospital NHS Foundation Trust
  • Portsmouth
    • Southsea, Portsmouth, United Kingdom, PO5 3ND
      • Trafalgar Group Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Potential subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.

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:

Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomisation:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care alone (control); Multilayer/multi component compression bandaging treatment
Active Comparator: 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.	Device: geko™ medical device; The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
Active Comparator: 12 hours geko™; geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.	Device: geko™ medical device; The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Firstkind Ltd
• Investigators: Principal Investigator: Keith Harding, FRCGP FRCP FRCS, Welsh wound Innovation Centre

Publications and helpful links

General 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.
• Bull RH, Clements D, Collarte AJ, Harding KG. A Novel Randomized Trial Protocol for Evaluating Wound Healing Interventions. Adv Wound Care (New Rochelle). 2023 Sep 5. doi: 10.1089/wound.2023.0058. Online ahead of print.

Helpful Links

• Device official website
• Publication- Advances in Wound Care

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): August 9, 2022

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Leg Ulcer; VLU; Venous Leg Ulcer; Leg Wound
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: FSK-VLU-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No