NCT03396731

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Firstkind Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Venous Leg Ulcer
• Leg Ulcers Venous
• Leg Ulcer
• Wound Leg
• Wound

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-24
• Primary completion: 2022-05-17
• Completion: 2022-08-09
• First posted: 2018-01-11
• Last updated: 2023-09-21

Locations

23 sites across 1 country: United Kingdom