geko VLU efficacy study

  • Research type

    Research Study

  • Full title

    A Prospective, Multicentre, Randomised, Assessor Blinded Study Comparing the Efficacy and Patient Reported Outcomes of Two Different Daily gekoTM Treatment Duration in Conjunction with Standard Care, with each Other and to Standard Care Alone, in Patients with Venous Leg Ulcers

  • IRAS ID

    235092

  • Contact name

    Keith Harding

  • Contact email

    hardingkg@cardiff.ac.uk

  • Sponsor organisation

    Firstkind Medical

  • Clinicaltrials.gov Identifier

    NCT03396731

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    This study involves research. The purpose of the study is to investigate the most effective therapy for treating venous leg ulcers together with two different daily treatment durations (6hr and 12hr) of gekoTM device in together with standards care, with each other and to standard care alone.

    The geko™ device is a CE marked Medical Device. It’s about the size of a man’s wrist watch. It will be attached to the side of the knee.

    When switched on, it produces gentle painless electrical pulses. This will then contract the muscles of the lower leg, resulting in an increase in the blood flow to lower leg.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    18/LO/0219

  • Date of REC Opinion

    1 Feb 2018

  • REC opinion

    Further Information Favourable Opinion