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Procedure

Ewing Amputation for Peripheral Arterial Disease

N/A

Recruiting

Led By Luke P Brewster, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Veterans requiring major amputation due to infection that includes the ankle retinaculum

Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a training protocol for a new surgical procedure is feasible and effective, as well as whether the surgical team can retain Veterans who participate in the trial.

Who is the study for?

This trial is for Veterans with Peripheral Arterial Disease who need a below-knee amputation but have good blood flow to heal. They should be interested in rehabilitation and able to walk with a prosthesis after surgery. Those with severe kidney disease, major infections including the ankle, or poor blood flow not suitable for healing are excluded.

What is being tested?

The study tests Ewing Amputation (EA) feasibility over two years at AVAMC. It involves training surgeons in EA techniques and assessing their competence. Participants will undergo EA and follow a postoperative protocol for six months, aiming to recruit 30 Veterans and achieve at least 70% complete follow-up.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of surgical procedures like Ewing Amputation may include pain, infection risk at the surgery site, issues related to anesthesia, and potential complications during rehabilitation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a veteran needing a major amputation because of an infection that includes the ankle area.

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I am a veteran who cannot join in rehabilitation or use a prosthesis to walk.

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I am a veteran with severe kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Activities-specific Balance Scale

Amputee Mobility Predictor Questionnaire

Amputee Single Item Mobility Measure

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ewing AmputationExperimental Treatment1 Intervention

Single Arm Pilot Study : To implement lead-in surgeon training and test the feasibility of recruiting and retention of veterans undergoing Ewing Amputation in a single arm study at Atlanta VAMC.

0 / 3Eligibility criteria met