Treatment for Peripheral Arterial Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, GA
Peripheral Arterial Disease+1 More
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The objective is to quantify in 2 years the feasibility of recruiting and retaining Veterans at the AVAMC in an EA protocol. The investigators will implement a training protocol for AMI and RPNI. The investigators will document competence and timing to competence for the AVAHCS surgical team. The investigators will perform EA in AVAHCS Veterans who meet inclusion/exclusion parameters and elect EA surgical intervention. Veterans will then participate in the investigators' postoperative protocol out to 6 months. The criteria to moving to phase 2 includes clinically consenting and and performing EA in 30 Veterans and collecting 6 months follow up data over 18 months at AVAHCS and 70% or better complete follow-up at 6 month time point after operation.

Eligible Conditions

  • Peripheral Arterial Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

14 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Activities-specific Balance Scale
Amputee Mobility Predictor Questionnaire
Amputee Single Item Mobility Measure
Berg Balance Scale
CRIS Fixed Form Instrument
Lower Extremity Amputee Data Collection Form
Lower Limb Mobility Rating Scale
PROMIS Numeric Rating Scale
Patient Timed Up and Go Test
Patient Two Minute Walk Test
Phantom and Residual Limb Questionnaire
RAND Health Survey
Self-Reported Falls Measure
Socket Comfort Score

Trial Safety

Trial Design

0 Treatment Group

30 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Atlanta VA Medical and Rehab Center, Decatur, GA · Decatur, GA
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2009First Recorded Clinical Trial
2 TrialsResearching Peripheral Arterial Disease
41 CompletedClinical Trials

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,459 Previous Clinical Trials
2,748,883 Total Patients Enrolled
9 Trials studying Peripheral Arterial Disease
688 Patients Enrolled for Peripheral Arterial Disease
Luke P Brewster, MDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are veterans with an expectation of participating in rehabilitation and resuming ambulation after amputation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.