Clinical trial NCT03396731: Efficacy Study for Geko Device in VLU Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Leg Ulcers Venous
Leg Ulcer
Wound Leg
Wound
Keywords: VLU
Venous Leg Ulcer
Leg Ulcer
Leg Wound
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2018-01-11
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Linear healing rate (LHR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Wound healing rate
timeFrame: Upto 8 weeks
measure: Pain reduction
timeFrame: Upto 8 weeks
measure: Change in Quality of Life
timeFrame: Upto 8 weeks
Other outcomes:
Locations:
city: Southsea
country: United Kingdom
facility: Trafalgar Group Medical Practice
state: Portsmouth
city: Addlestone
country: United Kingdom
facility: Crouch Oak Family Practice
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS foundation Trust
city: Bath
country: United Kingdom
facility: Heart of Bath Medical Partnership
city: Bristol
country: United Kingdom
facility: West Walk Surgery
city: Chippenham
country: United Kingdom
facility: Rowden Surgery
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Hebburn
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
city: Kings Lynn
country: United Kingdom
facility: The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
city: Leyland
country: United Kingdom
facility: Lancashire Care NHS Trust
city: London
country: United Kingdom
facility: Accelerate CIC
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Central London Community Healthcare
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Poole
country: United Kingdom
facility: The Adam Practice
city: Stevenage
country: United Kingdom
facility: Hertfordshire Community NHS Trust
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Thetford
country: United Kingdom
facility: Breckland Alliance
city: Wales
country: United Kingdom
facility: Welsh wound Innovation Centre
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Welsh Wound Innovation Centre
name: Keith Harding, FRCGP FRCP FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.