Join Clinical Trials for Peripheral Artery Disease
If you have been diagnosed with peripheral artery disease, or PAD, you know all too well the discomfort and pain that it can cause. Leg pain while walking (commonly referred to as intermittent claudication), cramping in the legs and hips, numbness and weakness, and coldness in the lower leg and foot are just a few of the bothersome symptoms that can occur as a result of PAD.
PAD results when narrowed arteries reduce blood flow to the legs. Although the legs are generally the most symptomatic of affected areas, PAD is usually an indication that a more widespread and severe problem is present – atherosclerosis – which may silently also be reducing the flow of blood to your heart and your brain.
If PAD is present, you are also at an increased risk for tissue death (commonly referred to as gangrene), which under severe circumstances, can necessitate amputation of the affected limb. In addition, since PAD is also an indication of more widespread atherosclerosis, individuals with PAD are at an increased risk for stroke and heart attack.
Thankfully, researchers are working to find better ways to diagnose and treat PAD, as well as working to develop better ways of managing symptoms such as pain, and stop the progression of atherosclerosis throughout the body. In addition, efforts aimed at increasing awareness among high-risk individuals, as well as working to prevent the development of PAD by monitoring and modifying risk factors are also underway.
What Will Peripheral Artery Disease Clinical Trials Be Like?
The types of tests and assessments used in PAD clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests used to evaluate the heart, heart functioning, and its impact on the body in general, many of which may be incorporated for use in clinical trials:
- Physical exam
- Ankle-brachial index (ABI): this common test is used to diagnose ABI and is performed by comparing the blood pressure in your ankle with the blood pressure in your arm.
- Ultrasound to evaluate blood flow through vessels and visualize blocked arteries.
- Angiography: a procedure during which a dye is injected into a vein in your arm and then viewed using a special x-ray machine, CT scanner, or MRI machine. This allows doctors to view the insides of the arteries that provide blood to your heart. Angiography may also be used to evaluate other blood vessels throughout the body.
- Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug
- Blood tests to check levels of cholesterol and triglycerides, as well as monitor for diabetes.
- Pain and quality of life assessments, as well as exercise diaries, may also be required in some studies, depending on the research question being studied.
Typical Peripheral Artery Disease Clinical Trial Protocol:
Specific examples of clinical trials for peripheral artery disease might include the following:
- A randomized clinical trial to compare standard medical treatment for PAD plus supervised exercise training to standard medical treatment only to determine if the addition of exercise training 1) improves patients’ quality of life; 2) improves overall circulation; and 3) reduces the risk of future major cardiovascular events (including heart attack and stroke.
- A randomized clinical trial in which patients with moderate PAD and high cholesterol, (and who are currently receiving cholesterol-lowering treatment) are treated with a prescription-strength fish oil preparation vs. placebo to determine if the drug helps to reduce or prevent the progression of atherosclerosis over the course of one year.
- A clinical trial to evaluate the safety and effectiveness of a biological therapy derived from an individual’s own cells as a potential treatment for PAD. In such a study, PAD patients would receive treatment with the biological product and then followed for a specific time period and observed for the occurrence of adverse events and improvements in PAD-related symptoms.
- An observational study in which the ABI of patients suffering from acute stroke is measured to determine to prevalence of PAD in a particular geographic population (e.g., all individuals admitted to a particular hospital for stroke over the course of six months).
A brief word about randomized trials and placebos:
Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.
On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.
Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.
In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the second clinical trial example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.
It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.
Trial Eligibility and Medical Information Needed:
The type of clinical trial you may be eligible for often depends on many factors, including your history of heart disease, your treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:
- Your prior history of heart disease
- Your prior history of treatment for PAD and heart disease (including any surgeries, procedures, and medications)
- Your current medications (including aspirin), vitamins, and dietary supplements.
- Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels
Suggested Search Terms:
Once you are ready to begin your search for PAD clinical trials, the following terms may be of use when combined with the phrase “peripheral artery disease”: “management,” “treatment,” “prevention,” “genetics,” “family history,” “rehabilitation,” “surgery,” “risk factors,” and “exercise.”
Current Search Term:
“Peripheral Artery Disease”
General Clinical Trial Information