A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884323
• Other study ID #: FSK-VLU-002
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: July 2, 2018

Study information

• Verified date: May 2022
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• geko™ device
The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.

Locations

Country	Name	City	State
United Kingdom	The University of Manchester Academic Surgery Unit 2nd Floor, ERC University Hospital of South Manchester M23 9LT	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours
Secondary	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.	2 hours
Secondary	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.	2 hours
Secondary	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	2 hours
Secondary	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.	2 hours