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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
7
The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.
The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT
Manchester, United Kingdom
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
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.
Time frame: 2 hours
The acute effect of the geko™ device on lower leg venous transit times
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.
Time frame: 2 hours
The acute effect of the geko™ device on wound tissue oxygen levels
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.
Time frame: 2 hours
The effect of the geko™ device on lower leg microcirculation
Laser Speckle contrast imaging will be applied to record images at baseline and with geko™ device
Time frame: 2 hours
Adverse events assessments
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.
Time frame: 2 hours
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