Firefly ANKLE Sprain Study

Grade I/II Ankle Sprain Clinical Trial

Official title:

Firefly ANKLE Sprain Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307955
• Other study ID #: FKD-ffANK-001
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2014
• Last updated: March 8, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Grade I/II Ankle Sprain

Intervention

Device:
• firefly

Other:
• Standard of care

Locations

Country	Name	City	State
United Kingdom	Poole NHS Trust Hospital	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oedema lower leg		1 week	No
Primary	FAAM ankle function measure		1 week	No
Secondary	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	No
Secondary	VAS Pain score		1 week	No
Secondary	Adverse event rate		1 week	Yes