Randomized Clinical Trial for Ewing Amputation in the VA

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special surgical procedure called Ewing Amputation (EA) for veterans with Peripheral Arterial Disease (PAD) who are scheduled to have a below-knee amputation (BKA). The goal is to see how well the researchers can recruit and keep veterans in the study over two years. They want to ensure that veterans have a good chance of healing after the surgery, and they will be closely monitoring participants for six months after their operation to gather important information about their recovery.

To be eligible for this study, veterans must have enough blood flow to heal after the amputation and be willing to participate in rehabilitation to learn how to walk again with a prosthesis. They should not have any major infections or conditions that would prevent them from healing properly or participating in physical therapy. If veterans choose to take part, they will receive specialized care and support during their recovery, helping them get back on their feet after surgery. The researchers aim to include at least 30 veterans in the study and ensure that most of them complete the follow-up assessments after six months.

Gender

ALL

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 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)