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Ankle foot orthosis for Peripheral Arterial Disease

N/A
Waitlist Available
Led By Sara A Myers, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
demonstrate positive history of chronic claudication
demonstrate exercise limiting claudication established by history and direct observation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months after intervention with the ankle foot orthosis.
Awards & highlights

Study Summary

This trial will test whether an ankle foot orthosis improves walking performance in patients with peripheral artery disease and will also examine the feasibility of this intervention.

Eligible Conditions
  • Peripheral Arterial Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
You have a history of chronic leg pain while walking.
Select...
You experience pain and discomfort while walking due to a medical condition called claudication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months after intervention with the ankle foot orthosis.
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months after intervention with the ankle foot orthosis. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum walking distance from the Gardner graded treadmill protocol.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ankle foot orthosisExperimental Treatment1 Intervention
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Group II: ControlActive Control1 Intervention
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ankle foot orthosis
2017
N/A
~120

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
533 Previous Clinical Trials
1,143,821 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
434 Patients Enrolled for Peripheral Arterial Disease
Sara A Myers, PhD5.06 ReviewsPrincipal Investigator - University of Nebraska
University of Nebraska

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants aged 65 and above?

"As stated in the study's criteria, patients must be between 40 and 85 years old to participate."

Answered by AI

Is my eligibility sufficient to participate in this experiment?

"This clinical trial is recruiting 50 individuals aged 40 to 85 with a diagnosis of peripheral arterial disease. To be eligible, participants must provide written consent and have demonstrated positive history of chronic claudication during exercise testing that resulted in an ankle/brachial index less than 0.90 at rest for at least 6 weeks along with stable blood pressure, lipid, and diabetes regimens."

Answered by AI

Is enrollment still available for this clinical trial?

"The information located on clinicaltrials.gov reveals that this trial is no longer actively looking for participants; the initial posting was made on July 7th 2017 and the last update happened October 29th 2022. Nonetheless, there are over 200 other medical studies currently open to recruitment."

Answered by AI
~7 spots leftby Mar 2025