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

NCT ID: NCT02316210

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Oedema Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Digitimer stimulation

Group Type EXPERIMENTAL

electrical stimulation

Intervention Type DEVICE

Interventions

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electrical stimulation

Intervention Type DEVICE

Other Intervention Names

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Digitimer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Firstkind Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BMI Harbour hospital

Poole, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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FKD-TURB-001

Identifier Type: -

Identifier Source: org_study_id

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