Ewing Amputation for Veterans with Peripheral Arterial Disease
This study is for Veterans with Peripheral Arterial Disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs, who need a below-knee amputation. It compares two types of surgery: Ewing Below Knee Amputation and Standard Below Knee Amputation. The Ewing amputation is a newer technique that aims to improve walking, reduce pain, and improve balance by maintaining muscle tension and sensation in the limb. Researchers want to see if the Ewing amputation helps Veterans walk better and feel more comfortable with their prosthetic leg, and if it reduces phantom limb pain (pain felt in a missing limb). You may be able to join if you are a Veteran with reasonable blood flow for healing and can participate in rehabilitation. This study is currently recruiting 120 participants.
- Study design
- This is a randomized study, meaning you would be assigned by chance to receive either the Ewing Below Knee Amputation or the Standard Below Knee Amputation. The study plans to enroll 120 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your comfort and pain will be measured at 12 months after the amputation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Randomized Clinical Trial for Ewing Amputation in the VA
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Luke P Brewster, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- PROMIS Numeric Rating Scale12 months
Patient reported rating scale to assess pain intensity and pain interference.
- Socket Comfort Score12 months
Patient reported rating scale to assess socket fit of prosthesis.
- Phantom and Residual Limb Questionnaire12 months
Patient reported questionnaire to assess sensation in phantom limb.
- Lower Extremity Amputee Data Collection Form12 months
Patient reported questionnaire to assess amputation system of care.
- Lower Limb Mobility Rating Scale12 months
Patient reported scale to assess movement with prosthetic leg.
- Amputee Single Item Mobility Measure12 months
Patient reported measure to assess current level of mobility.
- Activities-specific Balance Scale12 months
Patient reported scale to assess balance while performing every day activities.
- Self-Reported Falls Measure12 months
Patient reported one question survey to calculate falls in the previous month.
- RAND Health Survey12 months
Patient reported survey to assess general health while performing usual activities.
- CRIS Fixed Form Instrument12 months
Patient reported rating scale to assess usual activities in previous two weeks.
- Patient Two Minute Walk Test12 months
To measure distance patient can walk without assistance in 2 minutes.
- Patient Timed Up and Go Test12 months
To measure amount of time patient walks 3 meters.
- Berg Balance Scale12 months
To assess the patient's sitting and standing balance levels.
- Amputee Mobility Predictor Questionnaire12 months
To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.