NCT02316210

Brief Summary

This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

June 5, 2014

Last Update Submit

March 8, 2016

Conditions

OedemaNeuropathy

Outcome Measures

Primary Outcomes (1)

  • Observable foot twitch in response to stimulation with Digitimer DS7A

    Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured

    up to 2 hours

Secondary Outcomes (3)

  • adverse events

    up to 2 hours

  • oedema

    up to 2 hours

  • patient rated tolerability questionnaire

    up to 2 hours

Study Arms (1)

Digitimer stimulation

EXPERIMENTAL
Device: electrical stimulation

Interventions

electrical stimulationDEVICE
Also known as: Digitimer
Digitimer stimulation

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and over
  • Be a non-responder to the geko MK1\&2 device
  • Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
  • Able and willing to follow the protocol requirements.

You may not qualify if:

  • Has a pacemaker
  • Pregnancy.
  • Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
  • Recently diagnosed or suspected DVT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMI Harbour hospital

Poole, Dorset, BH15 2BH, United Kingdom

Location

MeSH Terms

Conditions

Edema

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

December 12, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

GB(1)