Ewing Amputation for Peripheral Arterial Disease

Recruiting at 2 trial locations

Overseen By Madhur Sancheti, MS

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: End-stage renal disease, Inadequate blood flow, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the Ewing Amputation treatment differ from other treatments for peripheral arterial disease?

The Ewing Amputation is a unique treatment for peripheral arterial disease as it involves the surgical removal of a limb, which is typically considered only in severe cases where other treatments have failed. This approach is distinct from other treatments that focus on improving blood flow or managing symptoms without removing the limb. ^{1 2 3 4 5}

Research Team

Luke P Brewster, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

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.

Inclusion Criteria

I am a veteran scheduled for or have had a below-knee amputation not due to infection, or I've had a treated foot infection below the ankle.

Veterans with good blood flow in the leg to heal a below-the-knee amputation.

I am a veteran planning to walk again and engage in physical therapy after my amputation.

Exclusion Criteria

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

Veterans who do not have enough blood flow to heal a below-the-knee amputation.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Ewing Below Knee Amputation or Standard Below Knee Amputation

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Ewing Amputation

Trial Overview 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.

Participant Groups

Group I: Ewing Amputation Experimental Treatment 2 Interventions

Randomized 1:1 clinical trial.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Particularities of peripheral arterial disease managed in vascular surgery in the French West Indies. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Epidemiology and pathophysiology of lower extremity peripheral arterial disease. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

The burden of amputation in patients with peripheral arterial disease in the Netherlands. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with early atherosclerosis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Left ventricular aneurysm and peripheral embolism as cause of atypical foot pain. [2004]