Ewing Amputation for Peripheral Arterial Disease

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of below-knee amputation called Ewing Amputation to determine if it helps Veterans with peripheral arterial disease (PAD) walk better and improve balance and pain compared to the standard method. Participants will be randomly assigned to receive either the Ewing Amputation or the standard procedure. It suits Veterans with good blood flow for healing, no infections, and an interest in rehabilitation and walking again after surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

What prior data suggests that the Ewing Amputation technique is safe for Veterans with PAD?

Research shows that the Ewing Amputation could be a promising new surgery for individuals requiring a below-the-knee amputation due to peripheral arterial disease (PAD). Although extensive safety data on the Ewing Amputation is not yet available, its current testing in clinical trials suggests earlier research found it reasonably safe.

Amputations for PAD can sometimes lead to complications. One study found that 16.8% of these surgeries had complications, and 12.3% of patients required additional surgery. While the procedure can be challenging, it is generally considered safe enough for trial testing.

The trial aims to compare the Ewing Amputation to the standard method, assessing whether the Ewing method might lead to better outcomes, such as improved walking ability and reduced pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ewing Amputation is unique because it offers a potentially less invasive approach to managing Peripheral Arterial Disease (PAD) compared to traditional treatments like bypass surgery or balloon angioplasty. Researchers are excited about this technique because it focuses on selectively amputating only the non-viable tissue in a precise manner, which could lead to faster recovery times and reduced complications. Unlike traditional methods that often address symptoms or rely on extensive surgical intervention, Ewing Amputation aims to directly remove the source of the problem while preserving as much healthy tissue as possible.

What evidence suggests that Ewing Amputation is effective for improving walking in Veterans with Peripheral Arterial Disease?

Research has shown that the Ewing Amputation technique, studied in this trial, may benefit people with peripheral arterial disease (PAD) requiring a below-knee amputation. This procedure aims to simplify prosthetic leg control and may help muscles feel more natural. Early results suggest it could improve walking by stabilizing the limb and reducing pain. This technique shows promise for enhancing balance and movement. Although more research is needed, initial findings are encouraging for those seeking better outcomes after amputation. ^{6 7 8 9 10}

Who Is on the Research Team?

Luke P Brewster, MD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6414116/

The Ewing Amputation: The First Human Implementation of ... The AMI offers the possibility of improved prosthetic control and restoration of muscle-tendon proprioception.

2. reporter.nih.gov reporter.nih.gov/project-details/8748641

Saving Life and Limb Electrical Stimulation for the Elderly with ... Preliminary investigations in our lab show when participants use this device for 8 weeks and walk an hour each day, ischemic pain is gone even after a full hour ...

3. ahajournals.org ahajournals.org/doi/10.1161/circresaha.116.303504

Surgical Intervention for Peripheral Arterial Disease High-quality data from several prospective studies shows annual 10% to 20% mortality for this patient population. The Circulase trial, a ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509624000530

Reconsidering the Impact of Endovascular Repair on Short ... In our experience, the impact of ER does not significantly change short-term and mid-term major outcomes in patients with PAD.

5. intcarper.com intcarper.com/articles/outcomes-and-predictors-of-amputation-after-endovascular-revascularization-in-diabetic-foot-disease-with-peripheral-artery-involvement/doi/intercardiopers.2025.2025-6-2

Outcomes and Predictors of Amputation After Endovascular ... Peripheral arterial disease (PAD) ... Amputation risk in patients with diabetes mellitus and peripheral artery disease using statewide data.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34597783/

Etiology and outcomes of amputation in patients ... - PubMed Outcomes after amputation remain poor regardless of whether they are categorized as major or minor. The pattern of amputation drivers in PAD ...

7. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.119.312859

Microvascular Disease Increases Amputation in Patients ... The emerging data that patients with both PAD and concomitant MVD experience a significantly greater risk of lower limb amputation than those ...

8. mdpi.com mdpi.com/2813-2475/4/2/23

Outcomes Following Peripheral Vascular Interventions in ... This study found that patients with PAD and ESRD have long hospital stays, high amputation rates, high readmission rates, and treatment failure.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5521961/

Outcomes of Critical Limb Ischemia in an Urban, Safety Net ... In this category, revascularization significantly decreased the risk of amputation by 25%.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0755498223000015

Lower-limb peripheral arterial disease and amputations in ... Complications were encountered in 16.8% of cases, and 12.3% required revision procedures. Notably, lower extremity amputations due to peripheral vascular ...