Back to resultsOptimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema (TURBO)
Primary Purpose
Oedema, Neuropathy
Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
electrical stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Oedema
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
- Pregnancy.
- Is contraindicated for the MK1&2 device and/or the Digitimer DS7A
- Recently diagnosed or suspected DVT
Sites / Locations
- BMI Harbour hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Digitimer stimulation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
adverse events
Any adverse events recorded during the study will be recorded
oedema
oedema will be measured to classify the level of swelling in the participants leg
patient rated tolerability questionnaire
Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02316210
Brief Title
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
Acronym
TURBO
Official Title
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oedema, Neuropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digitimer stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
electrical stimulation
Other Intervention Name(s)
Digitimer
Primary Outcome Measure Information:
Title
Observable foot twitch in response to stimulation with Digitimer DS7A
Description
Upon application of the electrical stimulation, parameters required to achieve an outward deflection of the foot will be measured
Time Frame
up to 2 hours
Secondary Outcome Measure Information:
Title
adverse events
Description
Any adverse events recorded during the study will be recorded
Time Frame
up to 2 hours
Title
oedema
Description
oedema will be measured to classify the level of swelling in the participants leg
Time Frame
up to 2 hours
Title
patient rated tolerability questionnaire
Description
Upon sufficient electrical stimulation to gain an outward deflection of the foot the patient will be asked to complete a tolerability questionnaire
Time Frame
up to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Pregnancy.
Is contraindicated for the MK1&2 device and/or the Digitimer DS7A
Recently diagnosed or suspected DVT
Facility Information:
Facility Name
BMI Harbour hospital
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2BH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
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