Geko Venous Leg Ulcer Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02482038

Enrollment

Registered

2015-06-25

Start date

2016-09-30

Completion date

2019-10-10

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer

Brief 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.

Interventions

DEVICEgeko

neuromuscular electrostimulator

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ultra sound measurements of haemodynamics	10mins

Secondary

Measure	Time frame	Description
Adverse event rate	2 hrs	—
patient rated tolerability	2 hrs	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026