OedemaEarly Phase 1TURBONCT02316210
Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
A Early Phase 1 study testing electrical stimulation in people with Oedema and Neuropathy, run by Firstkind Ltd at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oedema, Neuropathy
- What is being tested?
- electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Sep 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has a pacemaker
- Pregnancy.
- Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
- Recently diagnosed or suspected DVT
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy
- Conditions
- Oedema, Neuropathy
- Being tested
- electrical stimulation
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationDevice
Also called Digitimer
| Study group | Role | What they receive |
|---|---|---|
| Digitimer stimulation | Experimental | Not described Receives: Device: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 hours
Secondary outcomes (3)
adverse events
Any adverse events recorded during the study will be recorded
Measured: up to 2 hours
oedema
oedema will be measured to classify the level of swelling in the participants leg
Measured: up to 2 hours
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
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316210
- Sponsor's protocol ID
- FKD-TURB-001
- Acronym
- TURBO
- Status last verified
- Mar 2016
- First submitted
- 5 Jun 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
- ClinicalTrials.gov ID
- NCT02316210
- Acronym / sponsor ID
- TURBO / FKD-TURB-001
- Conditions
- Oedema, Neuropathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digitimer stimulation | Experimental | Device: electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Has a pacemaker
- Pregnancy.
- Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
- Recently diagnosed or suspected DVT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulationAlso: Digitimer | Device | Digitimer stimulation |
Primary outcome
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
3 secondary outcomes
adverse events
Time frame: up to 2 hours
oedema
Time frame: up to 2 hours
patient rated tolerability questionnaire
Time frame: up to 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing electrical stimulation in people with Oedema and Neuropathy, run by Firstkind Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observable foot twitch in response to stimulation with Digitimer DS7A (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.