Back to resultsA Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
Primary Purpose
Venous Leg Ulcer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
geko™ device
Sponsored by
About this trial
This is an interventional other trial for Venous Leg Ulcer
Eligibility Criteria
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)
Sites / Locations
- The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
geko device arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02884323
Brief Title
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
July 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
geko device arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
geko™ device
Intervention Description
The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
The acute effect of the geko™ device on lower leg venous transit times
Description
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
Title
The acute effect of the geko™ device on wound tissue oxygen levels
Description
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
Title
The effect of the geko™ device on lower leg microcirculation
Description
Laser Speckle contrast imaging will be applied to record images at baseline and with geko™ device
Time Frame
2 hours
Title
Adverse events assessments
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles McCollum
Organizational Affiliation
UHSM
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
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