Ankle FracturePhase 4NCT06772649
Compression Therapy for Swelling Management Following Ankle Injury
A Phase 4 study testing Compression sleeve in people with Ankle Fracture and Ankle Arthrodesis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture, Ankle Arthrodesis
- What is being tested?
- Compression sleeve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2025to 30 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, B3H 3A7
Devan Pancura, (902)473-7137, Devan.Pancura@nshealth.ca
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Ankle Fracture, Ankle Arthrodesis
- Being tested
- Compression sleeve
- Keywords
- non-operative ankle fracture management, operative ankle fracture management, ankle arthrodesis, mid-foot arthrodesis, hind-foot arthrodesis
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression sleeveOther
Also called Bauerfeind ankle 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.
| Study group | Role | What they receive |
|---|---|---|
| Bauerfeind Ankle Compression Sleeve | Experimental | 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. Receives: Other: Compression sleeve |
| Control | No 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swelling (volume)
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.
Measured: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Secondary outcomes (2)
Visual Analog Scale for Pain
Ankle pain will be measured using a standard Visual Analog Scale (VAS) to determine the level of pain a patient is experiencing.
Measured: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Product-Related Safety
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.
Measured: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FractureStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Bauerfeind
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772649
- Sponsor's protocol ID
- BSWELL-001
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Efficacy of Compression Therapy for Controlling Swelling in Post-Injury Ankle Management
- ClinicalTrials.gov ID
- NCT06772649
- Acronym / sponsor ID
- BSWELL-001
- Conditions
- Ankle Fracture, Ankle Arthrodesis
- Keywords
- non-operative ankle fracture management, operative ankle fracture management, ankle arthrodesis, mid-foot arthrodesis, hind-foot arthrodesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Bauerfeind
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bauerfeind Ankle Compression Sleeve | Experimental | Other: Compression sleevePatients 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. |
| Control | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression sleeveAlso: Bauerfeind ankle compression sleeveThe 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 | Bauerfeind Ankle Compression Sleeve |
Primary outcome
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.
2 secondary outcomes
Visual Analog Scale for Pain
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compression sleeve in people with Ankle Fracture and Ankle Arthrodesis, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devan Pancura, MSc ((902)473-7137, Devan.Pancura@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swelling (volume) (time frame: 6 weeks, 12 weeks, and 24 weeks post-injury/post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.