Efficacy Study for Geko Device in VLU Patients

Not Applicable

Completed

• Conditions: Leg Ulcers Venous; Wound; Venous Leg Ulcer; Leg Ulcer; Wound Leg
• Interventions: Device: geko™ medical device

• Registration Number: NCT03396731
• Lead Sponsor: Firstkind Ltd

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

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 Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Study Start: 2018-04-24
• Primary Completion: 2022-05-17
• Study Completion: 2022-08-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 hours geko™	geko™ medical device	geko™ device 12 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.
6 hours geko™ (no longer recruiting)	geko™ medical device	geko™ device 6 hours daily for 4 weeks treatment phase, to be used in conjunction with Standard of care.

Primary Outcome Measures

Name	Time	Method
Linear healing rate (LHR)	8 weeks	Linear healing rate will be studied on a weekly basis

Secondary Outcome Measures

Name	Time	Method
Wound healing rate	Upto 8 weeks	Measured with the images taken
Pain reduction	Upto 8 weeks	Participant reported outcome of pain reduction using Visual Analogue Scale (VAS)
Change in Quality of Life	Upto 8 weeks	Change in Quality of Life based on participant reported outcomes using EQ-5D-5L questionnaire

Trial Locations

Locations (23)

Trafalgar Group Medical Practice; 🇬🇧 Southsea, Portsmouth, United Kingdom

Barnsley Hospital NHS foundation Trust; 🇬🇧 Barnsley, United Kingdom

Crouch Oak Family Practice; 🇬🇧 Addlestone, United Kingdom

Lancashire Care NHS Trust; 🇬🇧 Leyland, United Kingdom

Norfolk Community Health and Care NHS Trust; 🇬🇧 Norwich, United Kingdom

Musgrove Park Hospital; 🇬🇧 Taunton, United Kingdom

Welsh wound Innovation Centre; 🇬🇧 Wales, United Kingdom

Heart of Bath Medical Partnership; 🇬🇧 Bath, United Kingdom

South Tyneside NHS Foundation Trust; 🇬🇧 Hebburn, United Kingdom

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust; 🇬🇧 Kings Lynn, United Kingdom

Rowden Surgery; 🇬🇧 Chippenham, United Kingdom

Accelerate CIC; 🇬🇧 London, United Kingdom

West Walk Surgery; 🇬🇧 Bristol, United Kingdom

York Teaching Hospital NHS Foundation Trust; 🇬🇧 York, United Kingdom

Lakeside Healthcare; 🇬🇧 Corby, United Kingdom

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Royal Devon & Exeter NHS Foundation Trust; 🇬🇧 Exeter, United Kingdom

Central London Community Healthcare; 🇬🇧 London, United Kingdom

The Adam Practice; 🇬🇧 Poole, United Kingdom

Hertfordshire Community NHS Trust; 🇬🇧 Stevenage, United Kingdom

Breckland Alliance; 🇬🇧 Thetford, United Kingdom

Worcestershire Royal Hospital; 🇬🇧 Worcester, United Kingdom

Royal Free London NHS Foundation Trust; 🇬🇧 London, United Kingdom