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NCT Number: NCT02884323

A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester.

Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT

Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Intact healthy skin at the site of device application
  • Able to understand the Patient Information Sheet
  • Willing and able to give informed consent
  • Willing and able to follow the requirements of the protocol
  • Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 1 cm2 and less than 10 cm in maximum diameter,
  • ABPI of ≥0.8
  • Patient treated with 4 layer compression bandaging

Exclusion criteria

  • Wound infection either acute or chronic
  • History of significant haematological disorders or DVT with the preceding six months
  • Pregnant
  • Pacemakers or implantable defibrillators
  • Use of any other neuro-modulation device
  • Current use of TENS in pelvic region, back or legs
  • Use of investigational drug or device within the past 4 weeks that may interfere with this study
  • Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
  • Recent trauma to the lower limbs
  • Size of leg incompatible with the geko™ device.
  • Obesity (BMI > 34)
  • Any medication deemed to be significant by the Investigator
  • Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
  • Diabetes
  • Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Treatment and study plan

geko™ device

Device

The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.

Primary outcomes

  1. The acute effect of the geko™ device on ambulatory venous pressure in patients with venous leg ulcers will be evaluated when sitting, standing or supine

    Time frame: 2 hours

    using Lectromed Multitrace II venous pressure recording system, this will measure Ambulatory venous pressure which will show any influence, if any, gekoTM has on AVP.

Secondary outcomes

  1. The acute effect of the geko™ device on lower leg venous transit times

    Time frame: 2 hours

    Using an ultrasound contrast agent to detect venous flow using Ultrasound imaging. Ultrasound images will be produced and a comparison of results between baseline and using geko™ device will be assessed.

  2. The acute effect of the geko™ device on wound tissue oxygen levels

    Time frame: 2 hours

    The patient will have multipsectral images taken of the ulcer using a fixed camera. The outcome measures (proportions of deoxy- and oxyhaemoglobin) will be displayed on an attached PC.

  3. The effect of the geko™ device on lower leg microcirculation

    Time frame: 2 hours

    Laser Speckle contrast imaging will be applied to record images at baseline and with geko™ device

  4. Adverse events assessments

    Time frame: 2 hours

    Patients will be monitored for adverse events throughout the duration of the study. Adverse events may be spontaneously reported by the subject, observed by the study personnel.

    Serious Adverse Events will be reported to the Sponsor, the National Research Ethics Service (NRES) recognised Research Ethics Committee.

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Official study title

A Single Centre Open Label Pilot Study Measuring Lower Limb Physiology in Patients With Venous Leg Ulcers Using the Geko™ T-2 or gekoTM Plus [R-2] Neuromuscular Electro Stimulation Device

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2016
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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