Compression Therapy for Swelling Management Following Ankle Injury

January 22, 2025 updated by: Nova Scotia Health Authority

Investigating the Safety and Efficacy of Compression Therapy for Controlling Swelling in Post-Injury Ankle Management

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study aims to assess swelling at 6, 12 and 26 weeks post non-operative and operative ankle fracture, mid-foot, hind-foot or ankle arthrodesis. Under current management, plaster casts are removed at six weeks and patients continue care in a walking boot. At this point in time of their recovery patients are permitted to weight bare and move in their walking boot without other aids. This has shown to cause a significant amount of swelling in the ankle and foot between week 6 and twenty-six post-injury/surgery.

To minimize swelling this study proposes the use of an ankle compression sleeve to wear during management once the plaster cast has been removed at 6 weeks. There is limited literature examining 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 as post ankle injury swelling can lead to wound complications and limit functionality. Thus, identifying management tools that reduce swelling may limit future complications.

Patients at the Queen Elizabeth II Health Sciences Centre that are undergoing non-operative ankle fracture management, ankle fracture surgery, or hind-foot, mid-foot, or ankle arthrodesis that meet the inclusion and exclusion criteria and willingly consent to the study will be included in the study's participant pool. Participants will be randomly assigned to control and intervention groups. Both groups will undergo a volume displacement swelling measurement of each foot at 6 weeks post operation/injury.

Patients in intervention group will be given a Bauerfeind ankle compression sleeve to wear under the walking boot for the rest of their management protocol. Patients will undergo volume displacement and compliance/ accessibility questionnaires during their twelve week and 6-month post operation/injury clinic visits. Data will be summarized and compared between groups and within groups at at 6, 12 and 26 weeks post operation/injury for change in swelling.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Science Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bauerfeind Ankle Compression Sleeve
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.
Other: Compression sleeve
The Bauerfeind compression sleeve is a fabric sleeve designed to support the ankle during movement. It's made of a compressive knit material that increases sensorimotor feedback, enhances blood circulation, and stimulates metabolism. The design helps reduce ligament strain, activates the foot's stabilizing muscles more quickly, and improves joint coordination.
Other Names:
  • Bauerfeind ankle compression sleeve
No Intervention: Control
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling (volume)
Time Frame: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Ankle swelling will be measured using a standard volume displacement test. Patients will place their foot in a tub of water of known volume, and the displaced volume will be measured. This procedure will be completed for both ankles.
6 weeks, 12 weeks, and 24 weeks post-injury/post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for Pain
Time Frame: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Ankle pain will be measured using a standard Visual Analog Scale (VAS) to determine the level of pain a patient is experiencing.
6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Product-Related Safety
Time Frame: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Safety of the Bauerfeind ankle compression sleeve will be determined by monitoring product-related adverse events. These could include things like skin irritation or reduced joint mobility due to use of the study product. All adverse events will be documented by severity and relationship to the study product.
6 weeks, 12 weeks, and 24 weeks post-injury/post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Bauerfeind

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSWELL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ankle Fracture

Clinical Trials on Compression sleeve

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe