Last updated on March 2020

Efficacy Study for Geko Device in VLU Patients

Brief description of study

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 Study 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

Clinical Study Identifier: NCT03396731

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