Last updated on August 2018

Efficacy Study for Geko Device in VLU Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Wound Leg | Trauma | Leg Ulcer | Varicose Ulcer
  • Age: Between 18 - 120 Years
  • Gender: Male or Female

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 2 cm2 and 20 cm2 in diameter at the study randomisation visit, i.e. Treatment Phase Visit 1 (TV1). The largest ulcer 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 from the study ulcer.
  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. Study ulcer has been treated with Standard Care (SC), i.e. multilayer, multicomponent, high level compression therapy, at one of the study sites during a minimum duration of four weeks prior to study entry (i.e. RV1).
  7. Ankle-Brachial Pressure Index (ABPI) of 0.8-1.2 inclusive measured at study entry or within 4 weeks prior to study entry (i.e. RV1).
  8. No active local or systemic infection for a minimum of 48 hours prior to study entry (i.e. RV1).
  9. No systemic antimicrobial treatment for a minimum of seven days prior to study entry (i.e. RV1).
  10. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

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 high level 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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