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Geko Venous Leg Ulcer Study

Primary Purpose

Venous Leg Ulcer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
geko
Sponsored by
Firstkind Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ealing Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

geko device

Arm Description

Outcomes

Primary Outcome Measures

Ultra sound measurements of haemodynamics

Secondary Outcome Measures

Adverse event rate
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

Full Information

First Posted
June 23, 2015
Last Updated
March 23, 2020
Sponsor
Firstkind Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02482038
Brief Title
Geko Venous Leg Ulcer Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
geko device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
geko
Intervention Description
neuromuscular electrostimulator
Primary Outcome Measure Information:
Title
Ultra sound measurements of haemodynamics
Time Frame
10mins
Secondary Outcome Measure Information:
Title
Adverse event rate
Time Frame
2 hrs
Title
patient rated tolerability
Description
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
Time Frame
2 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Intact healthy skin at the site of device application Able to understand the Patient Information Sheet Willing to give informed consent Willing to follow the requirements of the protocol 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, ABPI of 0.8 or greater Exclusion Criteria: History of significant haematological disorders or DVT with the preceding six months Pregnant Pacemakers or implantable defibrillators Use of any other neuro-modulation device Current use of TENS in pelvic region, back or legs Use of investigational drug or device within the past 4 weeks that may interfere with this study Recent surgery (such as abdominal, gynaecological, hip or knee replacement) Recent trauma to the lower limbs Size of leg incompatible with the geko™ device. Chronic obesity (BMI > 34) Any medication deemed to be significant by the Investigator Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension Diabetic subjects with advanced small vessel disease
Facility Information:
Facility Name
Ealing Hospital
City
Ealing
State/Province
Middlesex
ZIP/Postal Code
UB1 3EU
Country
United Kingdom

12. IPD Sharing Statement

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Geko Venous Leg Ulcer Study

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