NCT02307955

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

November 26, 2014

Last Update Submit

March 8, 2016

Conditions

Grade I/II Ankle Sprain

Outcome Measures

Primary Outcomes (2)

  • Oedema lower leg

    1 week

  • FAAM ankle function measure

    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

    1 week

  • VAS Pain score

    1 week

  • Adverse event rate

    1 week

Study Arms (2)

firefly

EXPERIMENTAL

participants treated with firefly device

Device: firefly

Control

OTHER

Standard of care

Other: Standard of care

Interventions

fireflyDEVICE
firefly
Standard of careOTHER
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poole NHS Trust Hospital

Poole, Dorset, BH15 2BH, United Kingdom

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 4, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

GB(1)