Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema (TURBO)

March 8, 2016 updated by: Firstkind Ltd
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Dorset
      • Poole, Dorset, United Kingdom, BH15 2BH
        • BMI Harbour hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digitimer stimulation
Device: electrical stimulation
Other Names:
  • Digitimer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observable foot twitch in response to stimulation with Digitimer DS7A
Time Frame: up to 2 hours
Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured
up to 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: up to 2 hours
Any adverse events recorded during the study will be recorded
up to 2 hours
oedema
Time Frame: up to 2 hours
oedema will be measured to classify the level of swelling in the participants leg
up to 2 hours
patient rated tolerability questionnaire
Time Frame: up to 2 hours
Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire
up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstkind Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 5, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKD-TURB-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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