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Clinical Trials/NCT02884323
NCT02884323CompletedNot Applicable

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

Firstkind Ltd2 sites in 1 country7 target enrollmentStarted: August 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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.
  • •Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Outcomes

Primary Outcomes

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

  • The acute effect of the geko™ device on lower leg venous transit times(2 hours)
  • Adverse events assessments(2 hours)
  • The acute effect of the geko™ device on wound tissue oxygen levels(2 hours)
  • The effect of the geko™ device on lower leg microcirculation(2 hours)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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