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Geko Venous Leg Ulcer Study

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ClinicalTrials.gov Identifier: NCT02482038
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Device: geko Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: geko device Device: geko
neuromuscular electrostimulator




Primary Outcome Measures :
  1. Ultra sound measurements of haemodynamics [ Time Frame: 10mins ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Intact healthy skin at the site of device application
  3. Able to understand the Patient Information Sheet
  4. Willing to give informed consent
  5. Willing to follow the requirements of the protocol
  6. 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,
  7. ABPI of 0.8 or greater

Exclusion Criteria:

  1. History of significant haematological disorders or DVT with the preceding six months
  2. Pregnant
  3. Pacemakers or implantable defibrillators
  4. Use of any other neuro-modulation device
  5. Current use of TENS in pelvic region, back or legs
  6. Use of investigational drug or device within the past 4 weeks that may interfere with this study
  7. Recent surgery (such as abdominal, gynaecological, hip or knee replacement)
  8. Recent trauma to the lower limbs
  9. Size of leg incompatible with the geko™ device.
  10. Chronic obesity (BMI > 34)
  11. Any medication deemed to be significant by the Investigator
  12. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension
  13. Diabetic subjects with advanced small vessel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482038


Locations
United Kingdom
Ealing Hospital Recruiting
Ealing, Middlesex, United Kingdom, UB1 3EU
Contact: Saroj Das, MD       'saroj.das@imperial.ac.uk'   
Contact: Mustapha Azzam, MD       'dr.azzam@yahoo.co.uk'   
Sponsors and Collaborators
Firstkind Ltd

Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT02482038     History of Changes
Other Study ID Numbers: FSK-VLU-001
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases