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Questions to Ask About the
Clinical Research Study |
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What is a clinical research study? |
| A clinical research study is conducted to answer specific questions about investigational
medications, therapies or ways of using known treatments. The purpose of clinical
research
studies (also called medical research or research studies) is to determine whether an
investigational drug or treatment is both safe and effective. The clinical study team will provide
potential study participants with an informed consent document for the study, which is a detailed
description of possible benefits, side effects, risks and any procedures a person will undergo.
This form should only be signed once the individual understands what is going to take place in
the study and if the physician has answered all questions. Participation in a clinical research trial
is completely voluntary. You may withdraw at any time. |
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Why should I be a participant in a clinical
research study? |
| Choosing to participate in a clinical research study is a personal decision. Study participants may
receive access to experimental research treatments before they are available to the general
public. They also may help others by contributing to medical research. It is often helpful to talk to
a physician, family members or friends about deciding to participate in a study. |
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| What is being studied? |
| The goal of this research study is to see if an investigational therapy is safe and effective for the
treatment of severe Peripheral Arterial Disease that has advanced to Critical Limb Ischemia. |
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| Who is eligible for the study? |
You may Qualify for this study if you:
| • | Are male or female, age 18 to 90 |
| • | Have a diagnosis of severe Peripheral Disease (Critical Limb Ischemia) |
| • | Have not undergone Kidney Dialysis for more
than 6 months |
| • | Are not currently being treated for Cancer |
| • | Have no surgeries planned |
Other eligibility criteria apply. |
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| What will be required of me? |
| If you qualify for this study, participation may last up to one year and will require approximately
eight face-to-face visits to the research office and one telephone interview. Throughout that time,
medical professionals with expertise in Critical Limb Ischemia will monitor you closely. |
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| Has this investigational treatment been tested on humans before? |
| Yes, the research study that is currently being conducted is called a Phase II study. This means
the investigational therapy you may receive has already been tested on humans in smaller
studies. |
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| What are the possible benefits, risks and side effects? |
| The study doctor will thoroughly discuss with you the possible benefits, risks and side effects
specific to the clinical study. |
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| Do I need to pay anything to participate in the clinical research study? |
| During your participation in the research study, the investigational therapy, study related
procedures and study visits will be provided to you at no cost. |
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| How can I find out more? |
| Please check clinicaltrials.gov for a full listing of participating sites. |
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