Ewing Amputation vs Standard Amputation for Peripheral Arterial Disease
Randomized Clinical Trial for Ewing Amputation in the VA
Recruiting
N/AInterventional Study
Peripheral Arterial Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
120 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for Veterans with Peripheral Arterial Disease who need a below knee amputation. Participants will be randomly assigned to receive either an Ewing amputation or a standard amputation.
Are You a Good Fit for This Trial?
You may be able to join if
I have reasonable blood flow to heal a below knee amputation.
I expect to participate in rehabilitation and walk again after the amputation.
I will have a below knee amputation for reasons other than infection.
I have had a foot infection below the ankle that has been treated.
You may not be able to join if
I have end-stage renal disease.
I need a major amputation due to an infection that includes the ankle.
I do not have enough blood flow to heal a below knee amputation.
I cannot participate in rehabilitation or walk with a prosthesis.
I was already assigned to another limb for this trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
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