NCT05437562 · VA Office of Research and Development
Randomized Clinical Trial for Ewing Amputation in the VA
What this study is about
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 randomly assigned study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation.
View original scientific description
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.
Interventions
PROCEDURE
Ewing Below Knee Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
PROCEDURE
Standard Below Knee Amputation
Standard Below Knee Amputation
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Decatur, Georgia
- Nashville, Tennessee
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 9, 2026 · Source of record for eligibility and locations