Compression Therapy for Swelling Management Following Ankle Injury

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority

About this trial

After an injury or undergoing foot/ankle surgery, patients often experience swelling in the injured area. Under current standard of care, plaster casts are removed at six weeks and patients are put in a walking boot. At this point in time of their recovery, patients are permitted to weight bear and move in their walking boot without other help, like crutches. This has shown to cause a significant amount of swelling in the ankle and foot between week six and twenty-six post-injury/surgery.

There is not much research that has looked at the effects of compression on reducing swelling in post-operative and non-operative ankle fracture, mid-foot, hindfoot, or ankle arthrodesis. This research is important because post-injury swelling can lead to wound complications and limit functionality. Therefore, finding new ways to reduce swelling could help prevent future complications.

The purpose of this study is to see if the Bauerfeind ankle compression sleeve is a safe post-operative/injury foot and ankle swelling management tool. Use of a compression sleeve will be compared to just using a walking boot, which is current standard of care, to determine if the compression sleeve reduces post-operative/injury foot and ankle swelling.

The study will follow patients improvement in swelling and pain. The compression sleeve will also be assessed for product safety. Safety is determined by watching the frequency, severity and seriousness of any side effects or complications, known as adverse events, that may be experienced while in the study.

The Bauerfeind ankle compression sleeve has been and is currently used in humans as a swelling reducing devise in the foot and ankle but has not been studied in a randomized control trial.

Eligibility criteria

Qualifiers

Patients undergoing outpatient ankle, mid-foot or hindfoot arthrodesis, fracture surgery, or non-operative ankle fracture management at the Queen Elizabeth II Health Sciences Center.

Aged 18 or over

Disqualifiers

Patients undergoing other ankle procedures

Patients who have any signs of wound healing complications post-surgery

Patients who are unable to progress to walking boot and weight-bearing management at 6 weeks post operation/injury.

Patients with other co-morbidities that may create bias within the results (lymphedema, heart conditions etc.)

Trial design

Treatments tested in this trial

  • Compression sleeve

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators