Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2014-09-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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firefly
participants treated with firefly device
firefly
Control
Standard of care
Standard of care
Interventions
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firefly
Standard of care
Eligibility Criteria
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Inclusion Criteria
2. Referred to physiotherapy for treatment of ankle sprain
3. Clinical diagnosed ankle sprain with evidence of swelling
4. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements
Exclusion Criteria
2. Evidence of fracture
3. Has a pacemaker
4. Chronic Obesity (BMI Index \>40kg/m2).
5. Pregnancy.
6. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
7. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
8. Not able to fit firefly device
18 Years
ALL
No
Sponsors
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Firstkind Ltd
INDUSTRY
Responsible Party
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Locations
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Poole NHS Trust Hospital
Poole, Dorset, United Kingdom
Countries
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Other Identifiers
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FKD-ffANK-001
Identifier Type: -
Identifier Source: org_study_id
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