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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: geko

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Ealing, Middlesex, United Kingdom, UB1 3EU
      • Ealing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: geko device	Device: geko; neuromuscular electrostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ultra sound measurements of haemodynamics	10mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate		2 hrs
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

Collaborators and Investigators

• Sponsor: Firstkind Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: FSK-VLU-001