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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activities-specific Balance Scale
Amputee Mobility Predictor Questionnaire
Amputee Single Item Mobility Measure
+11 moreTrial 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,154 Total Patients Enrolled
12 Trials studying Peripheral Arterial Disease
982 Patients Enrolled for Peripheral Arterial Disease
Luke P Brewster, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran needing a major amputation because of an infection that includes the ankle area.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 who do not have enough blood flow to heal a below-the-knee amputation.Veterans with good blood flow in the leg to heal a below-the-knee amputation.I am a veteran who cannot join in rehabilitation or use a prosthesis to walk.I am a veteran planning to walk again and engage in physical therapy after my amputation.I am a veteran with severe kidney failure.
Research Study Groups:
This trial has the following groups:- Group 1: Ewing Amputation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of this research project's cohort?
"Affirmative. Clinicaltrials.gov's records reveal that this medical experiment, which was initially posted on October 1st 2022 is actively recruiting volunteers. 30 subjects need to be enrolled at one site in order for the trial to proceed as planned."
Answered by AI
Are researchers still accepting volunteers for this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which was first posted on October 1st 2022 and recently updated on the 28th of October, is in search for 30 test subjects from one medical centre."
Answered by AI
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