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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Compression Sleeve for ankle injury?

Research shows that compression therapy, like compression sleeves, can help reduce swelling and pain after ankle injuries, such as sprains and fractures, and may speed up recovery. ^{1 2 3 4 5}

Is compression therapy safe for humans?

Research suggests that compression therapy, including compression bandages and stockings, is generally safe for humans. It has been used in various studies for conditions like ankle fractures and knee surgery, with no major safety concerns reported. ^{1 3 6 7 8}

How is the Compression Sleeve treatment for ankle injury different from other treatments?

The Compression Sleeve treatment for ankle injury is unique because it provides targeted compression to the affected area, which can help reduce swelling and support recovery. Unlike other treatments like braces or casts, the sleeve offers a flexible and comfortable option that can be worn continuously, potentially speeding up recovery from ankle sprains. ^{2 3 4 9 10}

What is the purpose of 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

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.

I do not have other health issues like heart conditions that could affect the study.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Compression therapy after ankle fracture surgery: a systematic review. [2018]

2. France pubmed.ncbi.nlm.nih.gov

The role of compression in the management of soft tissue ankle injuries: a systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Compression stockings in ankle sprain: a multicenter randomized study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effect of multilayer high-compression bandaging on ankle range of motion and oxygen cost of walking. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Wound complications after ankle surgery. Does compression treatment work? A randomized, controlled trial. [2019]

8. England 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. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Use of ankle-brachial pressure index to assess patient suitability for lower limb compression. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Management of leg ulcers]. [2010]