Compression Therapy for Ankle Injury

Overseen By Mark Glazebrook, PhD, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Nova Scotia Health Authority

Disqualifiers: Other ankle procedures, Wound complications, Lymphedema, Heart conditions, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special ankle compression sleeve can reduce swelling after an ankle injury or surgery. The study compares the sleeve to the standard care of using a walking boot to determine if it more effectively alleviates swelling and pain. It targets individuals who have undergone ankle or foot surgery or managed an ankle fracture without surgery and are beginning to walk again in a boot. This approach could provide a new method to prevent complications from swelling in the future. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand its benefits for a broader range of patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Bauerfeind ankle compression sleeve?

Research has shown that compression therapy, such as the Bauerfeind ankle compression sleeve, is generally safe. Other studies have used this type of sleeve and found it effective in reducing swelling and improving stability. Made from breathable fabric, it provides comfort and allows easy movement.

No major reports of serious side effects have emerged with these products. Users in sports find them effective and easy to tolerate. While monitoring for any discomfort is important, current evidence considers the sleeve safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Bauerfeind ankle compression sleeve because it offers a unique approach compared to the standard walking boot for ankle injuries. Unlike traditional methods that leave patients without any swelling aid after boot removal, this compression sleeve continues to provide support and potentially reduce swelling up to six months post-injury. The sleeve's ongoing compression could lead to better long-term recovery outcomes, which is a significant improvement over the current standard of care.

What evidence suggests that the Bauerfeind ankle compression sleeve is effective for reducing post-operative/injury foot and ankle swelling?

Research has shown that a Bauerfeind ankle compression sleeve can significantly reduce swelling and pain after ankle injuries, such as sprains and fractures. In this trial, participants in one arm will receive a Bauerfeind ankle compression sleeve at 6 weeks post-injury or post-operative. These sleeves apply steady pressure to improve blood flow and reduce swelling. This can lead to better stability and less pain, aiding faster recovery. Additionally, this therapy can enhance the body's ability to sense movement and position, potentially lowering the risk of future injuries. The sleeve is designed for comfort and breathability, allowing easy movement while working effectively. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have had an ankle injury or surgery, such as fractures or fusions. Participants should be at the stage where they can bear weight and move in a walking boot without crutches. The study excludes those with conditions that may interfere with the use of compression sleeves.

Inclusion Criteria

I am receiving foot or ankle treatment at the Queen Elizabeth II Health Sciences Center.

Exclusion Criteria

I am having other ankle surgeries.

I am experiencing complications in healing after surgery.

Patients who are unable to speak and read English, and/or in the opinion of the Principal Investigator are unable to provide fully informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants wear a plaster cast for initial recovery post-injury or surgery

6 weeks

1 visit (in-person) for cast removal

Intervention

Participants in the intervention group wear a Bauerfeind ankle compression sleeve under a walking boot

20 weeks

3 visits (in-person) at 6, 12, and 26 weeks post-injury/post-operative

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Compression Sleeve

Trial Overview

The trial is testing if using a Bauerfeind ankle compression sleeve alongside a walking boot reduces swelling more effectively than just using the boot alone after foot/ankle injuries or surgeries.

How Is the Trial Designed?

Group I: Bauerfeind Ankle Compression Sleeve Experimental Treatment 1 Intervention

Patients in this arm will be fitted for a Bauerfeind ankle compression sleeve at 6 weeks post-injury/post-operative following the removal of their walking boot. Patients will use the compression sleeve until 6 months post-injury/post-operative.

Group II: Control Active Control 1 Intervention

Patients in the control group will wear a walking boot until 6 weeks post-injury/post-operative. Upon removal of the boot, no swelling aid will be provided to patients (as per standard of care)

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Bauerfeind

Collaborator

Trials

2

Recruited

220+

Published Research Related to This Trial

A systematic review of 21 studies found that training programs are more effective than conservative treatments for improving pain and function in patients with chronic complaints after ankle sprains.

There is limited evidence suggesting that proprioceptive training can reduce the recurrence of ankle sprains, while the effectiveness of surgical treatments remains unclear due to a lack of comparative studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. van Ochten, JM., van Middelkoop, M., Meuffels, D., et al.[2022]

A large randomized controlled trial (RCT) involving 2600 adult patients will assess the efficacy of short-stretch compression bandages compared to standard bandaging after total knee arthroplasty, aiming to detect a significant improvement in patient-reported outcomes at 52 weeks.

The study will evaluate multiple outcomes, including knee pain and function (measured by the Oxford Knee Score), quality of life (EQ-5D scores), and complications, contributing valuable data to guide clinical practices in post-surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial. Cook, L., Northgraves, MJ., Fairhurst, C., et al.[2020]

Citations

1.

withpower.com

withpower.com/trial/phase-4-ankle-fractures-3-2025-af22b

Compression Therapy for Ankle Injury · Info for Participants

Research shows that compression therapy, like compression sleeves, can help reduce swelling and pain after ankle injuries, such as sprains and fractures, and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7890883/

People with chronic ankle instability benefit from brace ...

Our data reveal that maximum ankle inversion angles and velocities can be reduced during injury-relevant movements with a change of direction by ...

3.

bauerfeind.us

bauerfeind.us/ankle-compression-sleeve-sports-compression-ankle-support/?srsltid=AfmBOopB03tT-mhxJ6O-obTMbnmSEJ6sokHBg95KucBQ1XdjvtH2NiSI

Sports Compression Ankle Support

Targeted compression increases circulation for more energy and endurance · Improves proprioception to help limit the risk of injury · AirKnit fabric is breathable ...

4.

amazon.com

amazon.com/Bauerfeind-Sports-Ankle-Support-Breathability/dp/B0BYZZWBHB

Amazon.com: Bauerfeind Sports Ankle Support

The 3D AIRKNIT ankle brace is lightweight, comfortable, moisture-wicking and washable. It allows maximum freedom of movement and integrated adhesive zones ...

5.

bauerfeind.us

bauerfeind.us/ankle-braces/?srsltid=AfmBOorXA9kweijKg1Y6GYryV6iTuSrLT4pf9TUh7Fj3e38KRqgIIFBr

Ankle Braces & Supports

Bauerfeind's ankle braces, supports and compression sleeves relieve pain and improve stability to overcome ankle injuries and return to an active lifestyle.

6.

bauerfeind.us

bauerfeind.us/ankle-compression-sleeve-sports-compression-ankle-support/?srsltid=AfmBOoqHcDGBPt5WAOXkNYOuHmC6OpvE7jXgkNgJcJPFGf3HA-wVwxAF

Sports Compression Ankle Support

Targeted compression increases circulation for more energy and endurance · Improves proprioception to help limit the risk of injury · AirKnit fabric is breathable ...

7.

bauerfeind.us

bauerfeind.us/ankle-braces/?srsltid=AfmBOopUgBo3vl6-uhO-LodiXgroz2WL1dSRdPlmFu_hqddusbUSgScH

Ankle Braces & Supports

Bauerfeind's ankle braces, supports and compression sleeves relieve pain and improve stability to overcome ankle injuries and return to an active lifestyle.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5561773/

User Survey of 3 Ankle Braces in Soccer, Volleyball, and ...

Recurrence rates for ankle sprains are high. Therefore, preventive measures such as ankle bracing during sports are recommended.