Clinical trial NCT02884323: 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
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility 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 and able to give informed consent
5. Willing and able 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 1 cm2 and less than 10 cm in maximum diameter,
7. ABPI of ≥0.8
8. Patient treated with 4 layer compression bandaging

Exclusion Criteria:

1. Wound infection either acute or chronic
2. History of significant haematological disorders or DVT with the preceding six months
3. Pregnant
4. Pacemakers or implantable defibrillators
5. Use of any other neuro-modulation device
6. Current use of TENS in pelvic region, back or legs
7. Use of investigational drug or device within the past 4 weeks that may interfere with this study
8. Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
9. Recent trauma to the lower limbs
10. Size of leg incompatible with the geko™ device.
11. Obesity (BMI \> 34)
12. Any medication deemed to be significant by the Investigator
13. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
14. Diabetes
15. Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)

Primary outcomes:
measure: 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
timeFrame: 2 hours
Secondary outcomes:
measure: The acute effect of the geko™ device on lower leg venous transit times
timeFrame: 2 hours
measure: The acute effect of the geko™ device on wound tissue oxygen levels
timeFrame: 2 hours
measure: The effect of the geko™ device on lower leg microcirculation
timeFrame: 2 hours
measure: Adverse events assessments
timeFrame: 2 hours
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT
Study officials:
affiliation: UHSM
name: Charles McCollum
role: PRINCIPAL_INVESTIGATOR
References: