Geko Venous Leg Ulcer Study

Venous Leg Ulcer Clinical Trial

Official title:

A Single Centre Open Label Pilot Study Measuring Lower Limb Blood Flow 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: NCT02482038
• Other study ID #: FSK-VLU-001
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: October 10, 2019

Study information

• Verified date: March 2020
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to look at the effect of the geko device on the circulation in lower limbs of participants with venous leg ulcers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 10, 2019
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 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 to give informed consent

5. Willing 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 2 cm2 and less than 10 cm in maximum diameter,

7. ABPI of 0.8 or greater

Exclusion Criteria:

1. History of significant haematological disorders or DVT with the preceding six months

2. Pregnant

3. Pacemakers or implantable defibrillators

4. Use of any other neuro-modulation device

5. Current use of TENS in pelvic region, back or legs

6. Use of investigational drug or device within the past 4 weeks that may interfere with this study

7. Recent surgery (such as abdominal, gynaecological, hip or knee replacement)

8. Recent trauma to the lower limbs

9. Size of leg incompatible with the geko™ device.

10. Chronic obesity (BMI > 34)

11. Any medication deemed to be significant by the Investigator

12. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension

13. Diabetic subjects with advanced small vessel disease

Related Conditions & MeSH terms

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

Intervention

Device:
• geko
neuromuscular electrostimulator

Locations

Country	Name	City	State
United Kingdom	Ealing Hospital	Ealing	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultra sound measurements of haemodynamics		10mins
Secondary	Adverse event rate		2 hrs
Secondary	patient rated tolerability	A questionnaire has been designed to record the opinion of the patient with regard to the device, in particular how comfortable the device was to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable	2 hrs