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Ischemic Conditioning for Peripheral Arterial Disease
N/A
Recruiting
Led By Lindsay Slater, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 weeks
Summary
This trial will test the effects of ischemic conditioning (IC) on quadriceps strength and walking economy in individuals with lower limb amputation and peripheral artery disease.
Who is the study for?
This trial is for adults over 18 with a history of unilateral lower limb amputation due to peripheral artery disease, who can walk continuously for at least 10 minutes. They must not use walking aids and should have no neurological disorders affecting gait, heart failure, adverse reactions to ultrasound gel, thrombosis, sickle cell trait or hypertension.
What is being tested?
The study tests the effects of ischemic conditioning (IC), which involves repeated cycles of reduced blood flow followed by reperfusion on leg muscles. It aims to see if IC can strengthen quadriceps and improve walking efficiency in people with PAD after an amputation.
What are the potential side effects?
Potential side effects may include discomfort from the compression used during IC treatment and possible muscle fatigue. However, since this is non-invasive there are minimal risks compared to drug treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in gait kinematics
Change in gait kinetics
Body Weight Changes
+1 moreSecondary study objectives
Six-minute walk test
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ischemic Conditioning HighActive Control1 Intervention
Blood flow restriction with high compression
Group II: Ischemic Conditioning LowPlacebo Group1 Intervention
Blood flow restriction with low compression
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Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,074 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
146 Patients Enrolled for Peripheral Arterial Disease
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,453 Total Patients Enrolled
10 Trials studying Peripheral Arterial Disease
778 Patients Enrolled for Peripheral Arterial Disease
Lindsay Slater, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of having the sickle cell trait.You have had an amputation of one leg below or above the knee.You can walk for at least 10 minutes without needing to stop.You have a condition that affects how you walk.You have had heart failure in the past.You had a bad reaction to the gel used during an ultrasound.You have a history of blood clots.You have a history of high blood pressure.You have fallen two or more times in the past year.You have a medical condition that makes it unsafe for you to do tiring leg exercises or resist leg movements.You can walk without needing any assistance, like a cane.You have blood clots in your leg or any condition that makes it unsafe to compress your thigh or causes temporary lack of blood flow.You have had a head injury in the past 6 months.You have a history of seizures.You have been diagnosed with peripheral artery disease in the past.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Ischemic Conditioning Low
- Group 2: Ischemic Conditioning High
Awards:
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