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OpenTrials
Completed

NCT Number: NCT02482038

Geko Venous Leg Ulcer Study

This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ealing Hospital

Ealing, Middlesex, UB1 3EU, 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 to give informed consent
  • Willing to follow the requirements of the protocol
  • Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 2 cm2 and less than 10 cm in maximum diameter,
  • ABPI of 0.8 or greater

Exclusion criteria

  • 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 (such as abdominal, gynaecological, hip or knee replacement)
  • Recent trauma to the lower limbs
  • Size of leg incompatible with the geko™ device.
  • Chronic 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
  • Diabetic subjects with advanced small vessel disease

Treatment and study plan

geko

Device

neuromuscular electrostimulator

Primary outcomes

  1. Ultra sound measurements of haemodynamics

    Time frame: 10mins

Secondary outcomes

  1. Adverse event rate

    Time frame: 2 hrs

  2. patient rated tolerability

    Time frame: 2 hrs

    A questionnaire has been designed to record the opinion of the patient with regard to the device, in particular how comfortable the device was to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Official study title

A Single Centre Open Label Pilot Study Measuring Lower Limb Blood Flow 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
2019
First posted
Jun 25, 2015
Registry last updated
Mar 24, 2020

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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