Efficacy Study for Geko Device in VLU Patients

Status Completed

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03396731
Study type	Interventional
Source	Firstkind Ltd
Contact
Status	Completed
Phase	N/A
Start date	April 24, 2018
Completion date	August 9, 2022

View Details

See also
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