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OpenTrials
Completed

NCT Number: NCT02316210

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

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

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Key information

Conditions

Oedema Edema Neuropathy Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

BMI Harbour hospital

Poole, Dorset, BH15 2BH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Electrical Stimulation

Device

Other names: Digitimer

Primary outcomes

  1. 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

Secondary outcomes

  1. adverse events

    Time frame: up to 2 hours

    Any adverse events recorded during the study will be recorded

  2. oedema

    Time frame: up to 2 hours

    oedema will be measured to classify the level of swelling in the participants leg

  3. 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

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Acronym: TURBO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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