NCT02482038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

June 23, 2015

Last Update Submit

March 23, 2020

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

  • Ultra sound measurements of haemodynamics

    10mins

Secondary Outcomes (2)

  • Adverse event rate

    2 hrs

  • patient rated tolerability

    2 hrs

Study Arms (1)

geko device

EXPERIMENTAL
Device: geko

Interventions

gekoDEVICE

neuromuscular electrostimulator

geko device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ealing Hospital

Ealing, Middlesex, UB1 3EU, United Kingdom

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

September 1, 2016

Primary Completion

June 5, 2018

Study Completion

October 10, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

GB(1)