Peripheral Arterial DiseaseNCT05437562
Randomized Clinical Trial for Ewing Amputation in the VA
A study testing Ewing Below Knee Amputation and Standard Below Knee Amputation in people with Peripheral Arterial Disease, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment. The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ewing Below Knee Amputation and Standard Below Knee Amputation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Feb 2026to 2 Feb 2030
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veterans who have reasonable blood flow to heal a TTA (defined as palpable popliteal pulse or palpable femoral pulse with popliteal artery signal)
- Veterans with an expectation of participating in rehabilitation and resuming ambulation after amputation (defined by the Veteran interest, recent ambulation by the Veteran, ability to participate in physical therapy as deemed by the investigators' physical therapy team)
- Veterans who will be undergoing below knee amputation for reasons other than infection (uninfected patients) or Veterans who have had foot infection localized below the ankle (retinaculum uninfected) that has been adequately debrided and treated with appropriate antibiotic course.
Who cannot join
- Veterans with end-stage renal disease (ESRD)
- Veterans requiring major amputation due to infection that includes the ankle retinaculum
- Veterans deemed to have inadequate blood flow to heal a TTA
- Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason
- Veterans who were randomized for their other limb (to prevent Veteran from the possibility of having 2 different amputations)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Luke P Brewster, MD, 404-321-6111 ext. 7084, Luke.Brewster@va.gov
Luke P Brewster, MD
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Neal R Barshes, MD, 713-791-1414 ext. 25188, neal.barshes@va.gov
- Recruiting
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
John A Curci, MD, 615-873-7235, john.curci2@va.gov
About this study
Official title: Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment.
The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. If Veterans participate, they will be randomized to either Ewing Amputation or Standard Below Knee Amputation.
Read more
The scientific premise motivating this proposal is that Ewing Amputation is a promising surgical technique that may improve walking metrics in dysvascular Veterans by providing a better residual limb and improving pain and balance.
In preparation of this proposal, we have formed multi-disciplinary surgical teams at each site, and we have been supported by a clinical trial planning meeting to garner the considerable expertise in rehabilitation and amputee assessment from VA and DOD experts to assist in the design of this proposal, testing the overall hypothesis that: Ewing Amputation can help Veterans walk.
Read the detailed description
Major amputations lead to significant challenges for Veterans and their loved ones. Thus, amputations and the care of amputees are a major focus of the VHA. Hence, the tripartite goals of the VHA Amputation System of Care (ASoC) are to: provide state of the art care, maximize health and independence, and to be the provider of choice for amputated Veterans. Veterans undergo ~1000 transtibial amputations (TTA) annually, making TTA a commonly performed operation in the VA. Almost all Veterans requiring TTA are dysvascular with peripheral artery disease (PAD) and/or diabetes. TTA is a safe operation with a low 30-day mortality rate, and ambulation with prosthesis rates are much better for TTA versus transfemoral amputations (TFA). Since ~50% of Veterans are satisfied with their ambulation after major amputation, improving ambulation is an important benchmark forward in the care of Veterans. Importantly, the lower ambulation rates in Veterans are attributed to modifiable sequelae of major amputation, including: slower wound healing9,10; chronic pain, imbalance, and falls. Excitingly, new techniques can improve pain and balance and may improve wound healing/prevent falls. Ewing amputation (EA) recreates the agonist-antagonist myoneural interface (AMI) maintaining muscle tension, proprioception and limiting fibrofatty muscle degeneration of muscle flaps. EA also creates regenerative peripheral neural interfaces (RPNI) to improve pain control. Thus, EA may have a significant benefit to Veterans undergoing TTA.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ewing Below Knee Amputation, Standard Below Knee Amputation
- Keywords
- amputation
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ewing Below Knee AmputationProcedure or surgery
Ewing Below Knee Amputation - incorporates RPNI and AMI
Standard Below Knee AmputationProcedure or surgery
Standard Below Knee Amputation
| Study group | Role | What they receive |
|---|---|---|
| Ewing Amputation | Experimental | Ewing Below Knee Amputation - incorporates RPNI and AMI Receives: Procedure: Ewing Below Knee Amputation |
| Standard Below Knee Amputation | Experimental | Standard Below Knee Amputation Receives: Procedure: Standard Below Knee Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Numeric Rating Scale
Patient reported rating scale to assess pain intensity and pain interference.
Measured: 12 months
Socket Comfort Score
Patient reported rating scale to assess socket fit of prosthesis.
Measured: 12 months
Phantom and Residual Limb Questionnaire
Patient reported questionnaire to assess sensation in phantom limb.
Measured: 12 months
Lower Extremity Amputee Data Collection Form
Patient reported questionnaire to assess amputation system of care.
Measured: 12 months
Lower Limb Mobility Rating Scale
Patient reported scale to assess movement with prosthetic leg.
Measured: 12 months
Amputee Single Item Mobility Measure
Patient reported measure to assess current level of mobility.
Measured: 12 months
Activities-specific Balance Scale
Patient reported scale to assess balance while performing every day activities.
Measured: 12 months
Self-Reported Falls Measure
Patient reported one question survey to calculate falls in the previous month.
Measured: 12 months
RAND Health Survey
Patient reported survey to assess general health while performing usual activities.
Measured: 12 months
CRIS Fixed Form Instrument
Patient reported rating scale to assess usual activities in previous two weeks.
Measured: 12 months
Patient Two Minute Walk Test
To measure distance patient can walk without assistance in 2 minutes.
Measured: 12 months
Patient Timed Up and Go Test
To measure amount of time patient walks 3 meters.
Measured: 12 months
Berg Balance Scale
To assess the patient's sitting and standing balance levels.
Measured: 12 months
Amputee Mobility Predictor Questionnaire
To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start2 Feb 2026
- Primary completion2 Feb 2030 (estimated)
- Study completion2 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is evaluating an intervention in surgical technique for below knee amputation. The Veterans will be randomized to either Ewing amputation, which is a nuanced approach that incorporates RPNI and AMI to the standard below knee amputation. The standard below knee amputation is the comparison technique.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Luke P Brewster, MD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437562
- Sponsor's protocol ID
- SURG-001-21F
- Other IDs
- CX002366-01A1
- Status last verified
- Feb 2026
- First submitted
- 14 Jun 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
- ClinicalTrials.gov ID
- NCT05437562
- Acronym / sponsor ID
- SURG-001-21F
- Conditions
- Peripheral Arterial Disease
- Keywords
- amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 2 Feb 2030 (estimated)
- Study completion
- 2 Feb 2030 (estimated)
- First posted
- 29 Jun 2022 (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.
This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment.
The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. If Veterans participate, they will be randomized to either Ewing Amputation or Standard Below Knee Amputation.
The scientific premise motivating this proposal is that Ewing Amputation is a promising surgical technique that may improve walking metrics in dysvascular Veterans by providing a better residual limb and improving pain and balance.
In preparation of this proposal, we have formed multi-disciplinary surgical teams at each site, and we have been supported by a clinical trial planning meeting to garner the considerable expertise in rehabilitation and amputee assessment from VA and DOD experts to assist in the design of this proposal, testing the overall hypothesis that: Ewing Amputation can help Veterans walk.
Detailed description
Major amputations lead to significant challenges for Veterans and their loved ones. Thus, amputations and the care of amputees are a major focus of the VHA. Hence, the tripartite goals of the VHA Amputation System of Care (ASoC) are to: provide state of the art care, maximize health and independence, and to be the provider of choice for amputated Veterans. Veterans undergo ~1000 transtibial amputations (TTA) annually, making TTA a commonly performed operation in the VA. Almost all Veterans requiring TTA are dysvascular with peripheral artery disease (PAD) and/or diabetes. TTA is a safe operation with a low 30-day mortality rate, and ambulation with prosthesis rates are much better for TTA versus transfemoral amputations (TFA). Since ~50% of Veterans are satisfied with their ambulation after major amputation, improving ambulation is an important benchmark forward in the care of Veterans. Importantly, the lower ambulation rates in Veterans are attributed to modifiable sequelae of major amputation, including: slower wound healing9,10; chronic pain, imbalance, and falls. Excitingly, new techniques can improve pain and balance and may improve wound healing/prevent falls. Ewing amputation (EA) recreates the agonist-antagonist myoneural interface (AMI) maintaining muscle tension, proprioception and limiting fibrofatty muscle degeneration of muscle flaps. EA also creates regenerative peripheral neural interfaces (RPNI) to improve pain control. Thus, EA may have a significant benefit to Veterans undergoing TTA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is evaluating an intervention in surgical technique for below knee amputation. The Veterans will be randomized to either Ewing amputation, which is a nuanced approach that incorporates RPNI and AMI to the standard below knee amputation. The standard below knee amputation is the comparison technique.
| Arm | Type | Receives |
|---|---|---|
| Ewing Amputation | Experimental | Procedure: Ewing Below Knee AmputationEwing Below Knee Amputation - incorporates RPNI and AMI |
| Standard Below Knee Amputation | Experimental | Procedure: Standard Below Knee AmputationStandard Below Knee Amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans who have reasonable blood flow to heal a TTA (defined as palpable popliteal pulse or palpable femoral pulse with popliteal artery signal)
- Veterans with an expectation of participating in rehabilitation and resuming ambulation after amputation (defined by the Veteran interest, recent ambulation by the Veteran, ability to participate in physical therapy as deemed by the investigators' physical therapy team)
- Veterans who will be undergoing below knee amputation for reasons other than infection (uninfected patients) or Veterans who have had foot infection localized below the ankle (retinaculum uninfected) that has been adequately debrided and treated with appropriate antibiotic course.
Key exclusion criteria (5 listed)
- Veterans with end-stage renal disease (ESRD)
- Veterans requiring major amputation due to infection that includes the ankle retinaculum
- Veterans deemed to have inadequate blood flow to heal a TTA
- Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason
- Veterans who were randomized for their other limb (to prevent Veteran from the possibility of having 2 different amputations)
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 |
|---|---|---|
| Ewing Below Knee AmputationEwing Below Knee Amputation - incorporates RPNI and AMI | Procedure or surgery | Ewing Amputation |
| Standard Below Knee AmputationStandard Below Knee Amputation | Procedure or surgery | Standard Below Knee Amputation |
Primary outcome
PROMIS Numeric Rating Scale
Time frame: 12 months
Patient reported rating scale to assess pain intensity and pain interference.
Socket Comfort Score
Time frame: 12 months
Patient reported rating scale to assess socket fit of prosthesis.
Phantom and Residual Limb Questionnaire
Time frame: 12 months
Patient reported questionnaire to assess sensation in phantom limb.
Lower Extremity Amputee Data Collection Form
Time frame: 12 months
Patient reported questionnaire to assess amputation system of care.
Lower Limb Mobility Rating Scale
Time frame: 12 months
Patient reported scale to assess movement with prosthetic leg.
Amputee Single Item Mobility Measure
Time frame: 12 months
Patient reported measure to assess current level of mobility.
Activities-specific Balance Scale
Time frame: 12 months
Patient reported scale to assess balance while performing every day activities.
Self-Reported Falls Measure
Time frame: 12 months
Patient reported one question survey to calculate falls in the previous month.
RAND Health Survey
Time frame: 12 months
Patient reported survey to assess general health while performing usual activities.
CRIS Fixed Form Instrument
Time frame: 12 months
Patient reported rating scale to assess usual activities in previous two weeks.
Patient Two Minute Walk Test
Time frame: 12 months
To measure distance patient can walk without assistance in 2 minutes.
Patient Timed Up and Go Test
Time frame: 12 months
To measure amount of time patient walks 3 meters.
Berg Balance Scale
Time frame: 12 months
To assess the patient's sitting and standing balance levels.
Amputee Mobility Predictor Questionnaire
Time frame: 12 months
To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.
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 9 Feb 2026.
- 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.
Luke P Brewster, MD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ewing Below Knee Amputation and Standard Below Knee Amputation in people with Peripheral Arterial Disease, run by VA Office of Research and Development at 3 sites in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
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 Luke P Brewster, MD ((404) 321-6111 ext. 7084, Luke.Brewster@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Numeric Rating Scale (time frame: 12 months). The study lists 14 primary outcomes in all. 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 9 Feb 2026.