Firefly ANKLE Sprain Study

Firstkind

Status and phase: Completed; Phase 2

Conditions: Grade I/II Ankle Sprain

Treatments: Device: firefly; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02307955

FKD-ffANK-001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

firefly

Experimental group

Description:

participants treated with firefly device

Treatment:

Device: firefly

Control

Other group

Description:

Standard of care

Treatment:

Other: Standard of care