Grade I/II Ankle SprainPhase 2NCT02307955
Firefly ANKLE Sprain Study
A Phase 2 study testing firefly in people with Grade I/II Ankle Sprain, run by Firstkind Ltd at 1 site in United Kingdom.
Trial summary
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade I/II Ankle Sprain
- What is being tested?
- firefly
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 2
- 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
- Referred to physiotherapy for treatment of ankle sprain
- Clinical diagnosed ankle sprain with evidence of swelling
- 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 an ankle sprain grade 3
- Evidence of fracture
- Has a pacemaker
- Chronic Obesity (BMI Index >40kg/m2).
- Pregnancy.
- History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
- Not able to fit firefly device
Trial locations and contacts
1 site in 1 country.
About this study
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.
- Conditions
- Grade I/II Ankle Sprain
- Being tested
- firefly, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fireflyDevice
Standard of careOther
| Study group | Role | What they receive |
|---|---|---|
| firefly | Experimental | participants treated with firefly device Receives: Device: firefly |
| Control | Other | Standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oedema lower leg
Measured: 1 week
FAAM ankle function measure
Measured: 1 week
Secondary outcomes (3)
Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken
Measured: 1 week
VAS Pain score
Measured: 1 week
Adverse event rate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade I/II Ankle SprainStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02307955
- Sponsor's protocol ID
- FKD-ffANK-001
- Status last verified
- Mar 2016
- First submitted
- 26 Nov 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
- Firefly ANKLE Sprain Study
- ClinicalTrials.gov ID
- NCT02307955
- Acronym / sponsor ID
- FKD-ffANK-001
- Conditions
- Grade I/II Ankle Sprain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 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.
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| firefly | Experimental | Device: fireflyparticipants treated with firefly device |
| Control | Other | Other: Standard of careStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years and over
- Referred to physiotherapy for treatment of ankle sprain
- Clinical diagnosed ankle sprain with evidence of swelling
- 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 (8 listed)
- Has an ankle sprain grade 3
- Evidence of fracture
- Has a pacemaker
- Chronic Obesity (BMI Index >40kg/m2).
- Pregnancy.
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 |
|---|---|---|
| firefly | Device | firefly |
| Standard of care | Other | Control |
Primary outcome
Oedema lower leg
Time frame: 1 week
FAAM ankle function measure
Time frame: 1 week
3 secondary outcomes
Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken
Time frame: 1 week
VAS Pain score
Time frame: 1 week
Adverse event rate
Time frame: 1 week
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.
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 Phase 2 study testing firefly in people with Grade I/II Ankle Sprain, 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 5 inclusion and 8 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Oedema lower leg (time frame: 1 week). The study lists 2 primary outcomes in all. 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.