Ischemic Conditioning for Peripheral Arterial Disease

Overseen By Lindsay Slater, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Neurological disorder, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ischemic conditioning (IC) can strengthen leg muscles and improve walking for individuals with peripheral artery disease (PAD) and a lower limb amputation. IC involves briefly reducing and then restoring blood flow to the leg, potentially enhancing muscle strength and reducing the effort needed to walk. The trial compares two types of IC: one with high compression (active comparator) and another with low compression (sham comparator). Suitable candidates for this trial have PAD, a history of lower limb amputation, and can walk independently for at least 10 minutes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mobility and quality of life for individuals with similar conditions.

Do I have to stop taking my current medications for the trial?

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 ischemic conditioning is safe for individuals with peripheral arterial disease and a history of lower limb amputation?

Research has shown that ischemic conditioning (IC), which involves temporarily stopping blood flow to a limb and then allowing it to return, is usually safe for most people. Studies have found that this technique can boost muscle strength and reduce tiredness in both healthy individuals and those with muscle issues. However, some reports have mentioned possible side effects. Specifically, restricting blood flow might sometimes cause higher blood pressure and unusual heart reactions.

While many people undergo IC without any problems, awareness of these potential risks is important. Prospective trial participants should discuss these findings with their doctor to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ischemic conditioning for peripheral arterial disease because it offers a novel approach by using blood flow restriction as a form of therapy. Unlike traditional treatments like medications and surgical interventions that focus on improving blood flow through pharmacological or invasive means, ischemic conditioning uses controlled compression to potentially enhance blood circulation naturally. The "High" conditioning arm uses high compression to create a stronger effect, while the "Low" conditioning arm provides a comparison with minimal compression. This method could provide a non-invasive and low-risk alternative to current treatments, sparking interest due to its simplicity and potential effectiveness.

What evidence suggests that ischemic conditioning is effective for peripheral arterial disease?

Research has shown that ischemic conditioning (IC) can strengthen leg muscles and ease movement after an amputation. This trial will compare two approaches: Ischemic Conditioning High, which uses blood flow restriction with high compression, and Ischemic Conditioning Low, a sham comparator with low compression. IC involves briefly reducing and then restoring blood flow to the muscles, which has improved muscle performance in various groups, including those with peripheral artery disease (PAD). Studies indicate that IC can increase muscle strength and reduce fatigue, even in individuals with serious conditions like stroke. This enhancement in muscle strength and activity could aid walking and overall movement. Additionally, IC might improve muscle oxygen use, potentially reducing the energy needed for movement. These benefits could help those with amputations walk more easily and feel less fatigued. ^{2 3 6 7 8}

Who Is on the Research Team?

Lindsay Slater, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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 can walk without needing any assistance, like a cane.

Exclusion Criteria

You have a history of having the sickle cell trait.

You have a condition that affects how you walk.

You have had heart failure in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ischemic conditioning with either low or high compression to assess changes in quadriceps strength and gait mechanics

6 weeks

Weekly visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ischemic Conditioning High - Active Comparator
• Ischemic Conditioning Low - Sham Comparator

Trial Overview 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.

How Is the Trial Designed?

Group I: Ischemic Conditioning High Active Control 1 Intervention

Blood flow restriction with high compression

Group II: Ischemic Conditioning Low Placebo Group 1 Intervention

Blood flow restriction with low compression

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233322/

The effectiveness of blood flow restriction training in ... From these studies, current evidence suggests that BFR combined with low-load exercises can improve muscle strength, cardiovascular endurance, ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006427

Effect of Blood Flow Restricted Resistance Exercise and ... Our results demonstrate that BFRRE, but not RIC, improves functional capacity, quality of life, and muscle mitochondrial function.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296812/

Potential Short- and Long-Term Physiological Effects of ... Ischemic preconditioning (IPC) has emerged as a promising intervention for enhancing health- and exercise-related outcomes.

4. nature.com nature.com/articles/s41598-025-11654-y

Effects of different arterial occlusion pressures during blood ... Moderate damage corresponded to a 20–50% strength loss, with recovery occurring between 48 h and 7 days. Severe damage was characterized by a ...

5. ijspt.scholasticahq.com ijspt.scholasticahq.com/article/25791-the-systemic-effects-of-blood-flow-restriction-training-a-systematic-review

The Systemic Effects of Blood Flow Restriction Training This review found positive or neutral effects of blood flow restriction training on cardiovascular, endocrinological, musculoskeletal, and psychosocial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8963452/

A Useful Blood Flow Restriction Training Risk Stratification for ... BFRT may evoke increased blood pressure, abnormal cardiovascular responses and impact vascular health. Furthermore, some important concerns with the use of BFRT ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07043114?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22University%20Hospital,%20Bonn%22))&rank=8

Impact and Safety of Blood Flow Restriction in Patients ... The therapy of choice is regular gait training, a symptomatic therapy, as the initial cause, atherosclerosis, cannot be treated causally. In the ...

8. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajpheart.00468.2019

Clinical safety of blood flow-restricted training? A ... The present review synthesizes evidence that BFRT may elicit abnormal cardiovascular responses resulting from increased metaboreflex activation.