NCT02137499

Brief Summary

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

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

Study Start

First participant enrolled

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

October 11, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

May 12, 2014

Results QC Date

September 18, 2019

Last Update Submit

October 11, 2019

Conditions

Chronic Venous DiseaseVenous InsufficiencyDeep Venous Obstruction

Keywords

Deep venous obstructionVenous insufficiency

Outcome Measures

Primary Outcomes (1)

  • Percentage Change of Haemodynamic Flow

    Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.

    baseline, 20 minutes

Secondary Outcomes (2)

  • Improvement in Venous Symptoms

    6 weeks

  • Leg Volume

    6 weeks

Study Arms (4)

Healthy subjects

ACTIVE COMPARATOR

Healthy subjects, free from vascular disease

Device: geko device

Superficial venous insufficiency

EXPERIMENTAL

Clinically symptomatic and ultrasound evidence of superficial venous insufficiency

Device: geko device

Deep venous insufficiency

EXPERIMENTAL

Clinically symptomatic and ultrasound evidence of deep venous insufficiency

Device: geko device

Deep venous obstruction

EXPERIMENTAL

Clinically symptomatic and ultrasound evidence of deep venous obstruction

Device: geko device

Interventions

geko deviceDEVICE

Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

Deep venous insufficiencyDeep venous obstructionHealthy subjectsSuperficial venous insufficiency

Eligibility Criteria

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

You may not qualify if:

  • Group 2
  • Group 3
  • Group 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charing Cross Hospital

Hammersmith, London, W6 8RF, United Kingdom

Location

Related Publications (1)

  • Williams KJ, Moore HM, Ellis M, Davies AH. Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease. Vasc Health Risk Manag. 2021 Dec 1;17:771-778. doi: 10.2147/VHRM.S320883. eCollection 2021.

    PMID: 34880620DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Miss Kate Williams
Organization
Imperial College London
k.williams@imperial.ac.uk

Study Officials

  • Alun Davies

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 13, 2014

Study Start

August 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 25, 2019

Results First Posted

October 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)