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Clinical Trials/NCT02316210
NCT02316210
Completed
Early Phase 1

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

Firstkind Ltd1 site in 1 country25 target enrollmentMay 2014
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ConditionsOedemaNeuropathy

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Oedema
Sponsor
Firstkind Ltd
Enrollment
25
Locations
1
Primary Endpoint
Observable foot twitch in response to stimulation with Digitimer DS7A
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • •Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
  • •Recently diagnosed or suspected DVT

Outcomes

Primary Outcomes

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

  • adverse events(up to 2 hours)
  • oedema(up to 2 hours)
  • patient rated tolerability questionnaire(up to 2 hours)

Study Sites (1)

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