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CompletedNCT02307955Updated Mar 9, 2016

Firefly ANKLE Sprain Study

A Phase 2 interventional study of firefly and Standard of care in Grade I/II Ankle Sprain, sponsored by Firstkind Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by Firstkind Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Grade I/II Ankle Sprain
03

In context

Sprains and Strains

217 studies on the registry are indexed under Sprains and Strains; 44 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 166 interventional studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

Firstkind Ltd is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18 years and over
  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

Exclusion Criteria:

  1. Has an ankle sprain grade 3
  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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    firefly

    participants treated with firefly device

    Device: firefly

  • Other
    Control

    Standard of care

    Other: Standard of care

Interventions

  • Devicefirefly
  • OtherStandard of care
06

What researchers measure

Primary outcomes

  1. Oedema lower leg

    Time frame: 1 week

  2. FAAM ankle function measure

    Time frame: 1 week

Secondary outcomes

  1. 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

  2. VAS Pain score

    Time frame: 1 week

  3. Adverse event rate

    Time frame: 1 week

07

Study locations

1 site
  • Poole NHS Trust Hospital
    Poole, Dorset BH15 2BH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02307955
Lead sponsor
Firstkind Ltd
Responsible party
Sponsor
First posted
Dec 4, 2014
Start date
Sep 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Mar 9, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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