Amputation StumpEMPARNCT03948087
Comparison Between Postoperative Tubular Dressing and a Vacuum Removable Rigid Dressing After Transtibial Amputation
A study testing Vacuum Removable Rigid Dressing (VRRD) in people with Amputation Stump and Peripheral Vascular Disease With Complications, run by Covenant Health, Canada.
Trial summary
Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Stump, Peripheral Vascular Disease With Complications, Edema Leg
- What is being tested?
- Vacuum Removable Rigid Dressing (VRRD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2019to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Transtibial amputation related to peripheral vascular disease with or without diabetes or trauma.
- Justification: The form and function of the ORD device relates solely to transtibial amputees. The device is not useable for any other limb amputation type (e.g. transfemoral, transmetatarsal). The choice of using vascular compromised participants is intentional. Ischemia and necrosis rapidly ensue as a result of vessel occlusion which can easily happen with any external compressive force (e.g. tensor bandaging). The ORD does not apply compressive force to the residual limb.
- Transtibial amputation that includes myodesis and/or myoplasty.
- Justification: Myoplasty and myodesis are preferred surgical techniques while performing an amputation. They involve the surgical attachment of muscle to muscle (myoplasty) or muscle to bone (myodesis) across the end of the residual limb prior to skin flap closure. This allows increased stability and provides a better interface with a future prosthetic device.
- Greater than 18 years of age
- Justification: Below the age of 18 informed consent must be obtained by a parent or guardian
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- Patient must be able to speak and understand English in order to provide informed consent. No reliance on translator services will be implemented.
- Has no major illness where life expectancy is less than 2 years.
- Justification: This is the study timeline and co-morbidities that limit participation within this timeframe will introduce confounding factors.
Who cannot join
- Severe dementia or insufficient cognition.
- Justification: Inability to provide informed consent to participate in the study.
- Knee contracture greater than 30 degrees
- Justification: The ORD will not fit a limb with too much flexion at the knee. Wound healing is also affected due to pressure across the end of the residual limb without the use of offloading techniques.
- Severe peripheral vascular disease involving the contralateral lower limb
- Justification: Having severe peripheral vascular disease to the contralateral limb may affect the secondary outcome measures due to the need for further medical or surgical intervention.
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- Inability to speak, read, or understand English.
- Justification: For a patient to participate in the study informed consent must be obtained. There is a high probability that there would be too much variability among translators (family member or institutional) to ensure consistent informed consent.
- Neurological condition or medical disorder that could affect rehabilitation.
- Justification: Rehabilitation post transtibial amputation is critical to overall functional outcomes as well as study outcomes. If a patient has difficulty with participation in rehabilitation then this will be a confounding factor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Wound Healing, Edema Level, Knee Range of Motion, Protection Post Falls, Device Application, Time to Prosthetic Fit, and Cost Between Postoperative Soft Dressing and Vacuum Removable Rigid Dressing After Transtibial Amputation
Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.
Read the detailed description
The gold standard after transtibial amputation is casting of the residual limb to limit room for post-surgical edema, enable faster wound healing and shorter hospital stays, as well as, reduce time to prosthetic fitting. Casting also reduces the risk of impact damage to the limb. Casting, however, is costly and impractical due to the requirement of a prosthetist available on call for after emergency amputation surgeries and a need for multiple repeat prosthetist visits to cut off and reapply casting after wound healing checks. Thus current practice involves use of a compression elastic tube bandage (like a tensor bandage) applied within 15 minutes after surgery. However this bandage applies pressure to the residual limb, which can increase risk of reduced blood supply to the healing limb especially in vascular compromised patients. Further, this soft bandage does not offer any protection to the residual limb, a fall or severe contusion could lead to a requirement for costly revision surgery. There is evidence that rigid removable dressings can improve wound healing times, protect the limb, prevent contractures and enable earlier prosthetic fitting. This study aims to examine the the differences in wound healing time, changes in limb edema, knee range of motion, limb protection post falls, device application time, time to prosthetic fitting and cost between currently used postoperative soft dressing (SD) and vacuum removable rigid dressing (VRRD) after transtibial amputation.
- Conditions
- Amputation Stump, Peripheral Vascular Disease With Complications, Edema Leg, Wound Healing Delayed
- Being tested
- Vacuum Removable Rigid Dressing (VRRD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Removable Rigid Dressing (VRRD)Device
Also called Ossur (TM) Rigid Dressing (ORD)
Intra-operative application of device.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Removable Rigid Dressing (VRRD) | Experimental | Application of a Vacuum Removable Rigid Dressing (VRRD) Receives: Device: Vacuum Removable Rigid Dressing (VRRD) |
| Soft Dressing Control Group | No intervention | Application of standard of care soft dressing (SD) intra-operatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Change in Stump Wound Healing
The Photographic Wound Assessment Tool (PWAT) will be used in a blinded fashion to evaluate the level of change in wound healing of the transtibial amputation primary closure. The PWAT incorporates type and amount of necrotic tissue, wound edge definition, surrounding skin color, epithelialization, and granulation of tissue. A score of 0/24 on the PWAT indicates complete wound closure.
Measured: Day 3,7,14,30,48
Secondary outcomes (6)
Evaluation of Change in Level of Limb Edema
Circumferential measurements will be taken at two levels of the residual stump. Centimeters measured circumferentially at 5 cm from the distal end and around the knee at the center of the patella
Measured: Day 3,7,14,30,48
Evaluation of Change in Knee Range of Motion
Degrees measured via goniometry into knee flexion and extension for both active and passive range of motion.
Measured: Day 3,7,14,30,48
Rate of Revision Post Falls
Falls sustained by study participants will be recorded. Whether a follow-up revision surgery was necessary will also be recorded.
Measured: Until prosthetic limb fit, on average 2 months.
Total Amount of Time to Apply, Change, Clean and Alter the Dressings
Time log in minutes recorded by staff in real time providing care to study participants.
Measured: Until discharge from acute care, on average 2 weeks.
Length of time Until the Residual Limb is Ready for Prosthetic Fitting
Time log in days beginning post operative day 1 until the study participant is fit with a definitive prosthetic limb.
Measured: Through study completion, on average 2 months.
Total Length of Stay in Acute and Sub-acute Care Facilities
A time log in days of how long a given study participant is admitted to an acute or sub-acute care facility.
Measured: Through study completion, on average 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study startMay 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an interventional group (vacuum rigid removable dressing) vs a non-interventional group (standard of care control group of soft dressing application).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Covenant Health, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Principal investigator, Trent Duchscherer, Covenant Health, Canada
- Investigators
- Trent I Duchscherer, MSc, Principal investigator, Amputee Coordinator Northern Alberta Vascular CenterGerrit B Winkelaar, MD, Study director, Divisional Director and Clinical Head of Vascular Surgery for the Edmonton zone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948087
- Sponsor's protocol ID
- EMPAR
- Acronym
- EMPAR
- Status last verified
- May 2019
- First submitted
- 27 Feb 2019
- Last updated
- 13 May 2019
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wound Healing, Edema Level, Knee Range of Motion, Protection Post Falls, Device Application, Time to Prosthetic Fit, and Cost Between Postoperative Soft Dressing and Vacuum Removable Rigid Dressing After Transtibial Amputation
- ClinicalTrials.gov ID
- NCT03948087
- Acronym / sponsor ID
- EMPAR / EMPAR
- Conditions
- Amputation Stump, Peripheral Vascular Disease With Complications, Edema Leg, Wound Healing Delayed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Covenant Health, CanadaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- May 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 13 May 2019 (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.
Comparison of wound healing, edema level, knee range of motion, rate of revision post falls, device application time, time to prosthetic fit, and cost between postoperative soft dressing and a vacuum removable rigid dressing after unilateral transtibial amputation.
Detailed description
The gold standard after transtibial amputation is casting of the residual limb to limit room for post-surgical edema, enable faster wound healing and shorter hospital stays, as well as, reduce time to prosthetic fitting. Casting also reduces the risk of impact damage to the limb. Casting, however, is costly and impractical due to the requirement of a prosthetist available on call for after emergency amputation surgeries and a need for multiple repeat prosthetist visits to cut off and reapply casting after wound healing checks. Thus current practice involves use of a compression elastic tube bandage (like a tensor bandage) applied within 15 minutes after surgery. However this bandage applies pressure to the residual limb, which can increase risk of reduced blood supply to the healing limb especially in vascular compromised patients. Further, this soft bandage does not offer any protection to the residual limb, a fall or severe contusion could lead to a requirement for costly revision surgery. There is evidence that rigid removable dressings can improve wound healing times, protect the limb, prevent contractures and enable earlier prosthetic fitting. This study aims to examine the the differences in wound healing time, changes in limb edema, knee range of motion, limb protection post falls, device application time, time to prosthetic fitting and cost between currently used postoperative soft dressing (SD) and vacuum removable rigid dressing (VRRD) after transtibial amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an interventional group (vacuum rigid removable dressing) vs a non-interventional group (standard of care control group of soft dressing application).
| Arm | Type | Receives |
|---|---|---|
| Vacuum Removable Rigid Dressing (VRRD) | Experimental | Device: Vacuum Removable Rigid Dressing (VRRD)Application of a Vacuum Removable Rigid Dressing (VRRD) |
| Soft Dressing Control Group | No intervention | –Application of standard of care soft dressing (SD) intra-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Transtibial amputation related to peripheral vascular disease with or without diabetes or trauma.
- Justification: The form and function of the ORD device relates solely to transtibial amputees. The device is not useable for any other limb amputation type (e.g. transfemoral, transmetatarsal). The choice of using vascular compromised participants is intentional. Ischemia and necrosis rapidly ensue as a result of vessel occlusion which can easily happen with any external compressive force (e.g. tensor bandaging). The ORD does not apply compressive force to the residual limb.
- Transtibial amputation that includes myodesis and/or myoplasty.
- Justification: Myoplasty and myodesis are preferred surgical techniques while performing an amputation. They involve the surgical attachment of muscle to muscle (myoplasty) or muscle to bone (myodesis) across the end of the residual limb prior to skin flap closure. This allows increased stability and provides a better interface with a future prosthetic device.
- Greater than 18 years of age
Key exclusion criteria (10 listed)
- Severe dementia or insufficient cognition.
- Justification: Inability to provide informed consent to participate in the study.
- Knee contracture greater than 30 degrees
- Justification: The ORD will not fit a limb with too much flexion at the knee. Wound healing is also affected due to pressure across the end of the residual limb without the use of offloading techniques.
- Severe peripheral vascular disease involving the contralateral lower limb
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 |
|---|---|---|
| Vacuum Removable Rigid Dressing (VRRD)Also: Ossur (TM) Rigid Dressing (ORD)Intra-operative application of device. | Device | Vacuum Removable Rigid Dressing (VRRD) |
Primary outcome
Evaluation of Change in Stump Wound Healing
Time frame: Day 3,7,14,30,48
The Photographic Wound Assessment Tool (PWAT) will be used in a blinded fashion to evaluate the level of change in wound healing of the transtibial amputation primary closure. The PWAT incorporates type and amount of necrotic tissue, wound edge definition, surrounding skin color, epithelialization, and granulation of tissue. A score of 0/24 on the PWAT indicates complete wound closure.
6 secondary outcomes
Evaluation of Change in Level of Limb Edema
Time frame: Day 3,7,14,30,48
Evaluation of Change in Knee Range of Motion
Time frame: Day 3,7,14,30,48
Rate of Revision Post Falls
Time frame: Until prosthetic limb fit, on average 2 months.
Total Amount of Time to Apply, Change, Clean and Alter the Dressings
Time frame: Until discharge from acute care, on average 2 weeks.
Length of time Until the Residual Limb is Ready for Prosthetic Fitting
Time frame: Through study completion, on average 2 months.
Total Length of Stay in Acute and Sub-acute Care Facilities
Time frame: Through study completion, on average 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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. This study is not recruiting at the moment.
Trent I Duchscherer, MSc principal investigator
Amputee Coordinator Northern Alberta Vascular Center
Gerrit B Winkelaar, MD study director
Divisional Director and Clinical Head of Vascular Surgery for the Edmonton zone
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Removable Rigid Dressing (VRRD) in people with Amputation Stump and Peripheral Vascular Disease With Complications, run by Covenant Health, 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amputee Coordinator (780-735-7161, trent.duchscherer@covenanthealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Change in Stump Wound Healing (time frame: Day 3,7,14,30,48). 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 13 May 2019; AzTrials last refreshed its copy on 1 Nov 2026.