Firefly ANKLE Sprain Study | NCT02307955

Studies
Firefly ANKLE Sprain Study

NCT02307955

Sponsor

Firstkind Ltd

Status

Completed

Last Update Posted

Mar 9, 2016Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

Grade I/II Ankle Sprain

Interventions

firefly
Standard of care

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Nov 26, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
firefly	Experimental	participants treated with firefly device	Device: firefly
Control	Other	Standard of care	Other: Standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
firefly	Device		firefly
Standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oedema lower leg		1 week
FAAM ankle function measure		1 week

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poole NHS Trust Hospital		Poole	Dorset	BH15 2BH	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided