Efficacy Study for Geko Device in VLU Patients

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396731
• Other study ID #: FSK-VLU-004
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: August 9, 2022

Study information

• Verified date: September 2023
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: August 9, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Leg Ulcers Venous
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer
• Wound
• Wound Leg
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
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	Central London Community Healthcare	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Norfolk Community Health and Care NHS Trust	Norwich
United Kingdom	The Adam Practice	Poole
United Kingdom	Trafalgar Group Medical Practice	Southsea	Portsmouth
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

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear healing rate (LHR)	Linear healing rate will be studied on a weekly basis	8 weeks
Secondary	Wound healing rate	Measured with the images taken	Upto 8 weeks
Secondary	Pain reduction	Participant reported outcome of pain reduction using Visual Analogue Scale (VAS)	Upto 8 weeks
Secondary	Change in Quality of Life	Change in Quality of Life based on participant reported outcomes using EQ-5D-5L questionnaire	Upto 8 weeks

External Links

•   Device official website
•   Publication- Advances in Wound Care