Status:
COMPLETED
Firefly ANKLE Sprain Study
Lead Sponsor:
Firstkind Ltd
Conditions:
Grade I/II Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 oed...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02307955
Start Date
September 1 2014
End Date
January 1 2016
Last Update
March 9 2016
Active Locations (1)
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1
Poole NHS Trust Hospital
Poole, Dorset, United Kingdom, BH15 2BH