Bunion Removal Study

Available for qualified participants

Bunion Removal Study

Available for qualified participants

CenExel ACMR is currently seeking adult volunteers to participate in a bunion removal study.

Also known as hallux valgus, bunions are a progressive disorder that causes the big toe to lean toward the second toe. Eventually, it causes a disfigurement on the foot making it painful to wear shoes and walk. Causes for forming bunions include genetics, suffering from an inflammation condition, and wearing shoes that force the toes in unnatural positions. There are both non-surgical options (changes in footwear, wearing “bunion-shield” pads and shoe inserts, icing the foot, and medications) and surgical options for treatment for them.

Symptoms for a feet with bunions include:

  • A visible bump on the side of a foot near the toes
  • Pain and soreness
  • Redness and inflammation
  • Hardened skin on the bottom of the foot
  • A callus or corn on the bump
  • Difficulty walking and other activities due to foot discomfort

A bunionectomy is a type of surgery to remove a bunion and correct the deformity on the foot. The procedure is also referred to as a bunion removal and is necessary if non-surgical options do not help the pain caused by it. The amount of pain endured after a bunionectomy varies per person and often pain medication is prescribed for your post-operative care. Medical researchers are looking for better alternatives for this type of medication. If you need a bunion surgically removed, contact us about your bunionectomy and consider a clinical trial to help advance the search for better pain management for your recovery.

FAQs

What is a Bunion?

A bunion (hallux valgus) is a deformity of the metatarsophalangeal (MTP) joint at the base of the big toe. A bunion develops when the big toe pushes against the other toes, sometimes diving over or under them. As a result, the base of the big toe – the metatarsophalangeal (MTP) joint – juts or angles out from the foot.

What Causes a Bunion?

Shoes with narrow toes can trigger a bunion, but they’re not the underlying cause. Bunions run in families, because foot type (shape and structure) is hereditary, and some types are more prone to bunions than others.

Low arches, flat feet, and loose joints and tendons all increase the risk. The shape of the metatarsal head (the top of the first metatarsal bone) also makes a difference: if it’s too round, the joint is less stable and more likely to deform when squeezed into shoes with narrow toes.

High heels can exacerbate a potential bunion problem because they tip the body’s weight forward, forcing the toes into the front of the shoe. This may help to explain why bunions are 10 times more common in women than in men.

People in occupations such as teaching and nursing, that involve a lot of standing and walking, are more susceptible to bunions. Ballet dancers, whose feet suffer severe repetitive stress, are also amongst those who experience bunions. Women can sometimes develop bunions and other foot problems during pregnancy because hormonal changes loosen the ligaments and flatten the feet. Bunions are also associated with arthritis, which damages the cartilage within the joint.

Why Bunions Should be Treated

The MTP joint helps us bear and distribute weight during a range of activities. A bunion at this critical junction of bones, tendons, and ligaments can seriously impair the foot’s ability to function. A bunion on the big toe can damage the other toes. Under the pressure of the big toe, they may develop corns or become bent, forming “hammertoes.” Toes with bunions often have nails that become ingrown. Calluses may form on the bottom of the foot. If you constantly shift your weight off the painful big toe joint to other metatarsals, you may also develop discomfort in the ball of the foot. As the misshapen joint becomes more uncomfortable and harder to fit into shoes, exercise and other activities, even walking, may become difficult.

Foot disorders are a major cause of disability and sedentary habits in older women. A foot study that involved almost 3,000 women and men, ages 56 and older, found that women are more likely to have bunions as they get older, and the more severe their bunions are, the lower their quality of life. Bunion pain and deformity usually interfered with daily routines and physical activity.

Bunions Removal and Treatment Options

There are multiple surgical procedures available to treat bunions. Determining which type of bunion correction is appropriate often depends upon the severity of the bunion, the age of the patient, and deformity of the foot. ACMR Clinical Research’s bunion clinical trial offers bunion removal for participation in the study and may include compensation for study-related time.

If you are interested in finding out if you could be a candidate for this pain associated with bunion removal study, please fill out the form on this page. A representative from CenExel ACMR will be in contact with you to discuss your eligibility and next steps.

 
To be considered, please fill out the form or call 404-881-5800.

STUDY DETAILS

No cost studies are currently available for qualified participants.

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No health insurance required

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Compensation for meal and travel up to $2,450

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Male / Female

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18-80 years old

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501 Fairburn Road SW
Atlanta, GA 30331

Research Pharmacy
State-of-the-art Facilities

As a former hospital, CenExel ACMR is the largest independent medical research facility ever constructed. Every aspect of the infrastructure was designed for healthcare best practices, making it a perfect setting for conducting clinical trials. 

Kimball Johnson
Board-certified Physicians

Your safety is our greatest concern. Every study at CenExel ACMR is overseen by expert medical staff and performed by some of the most well-respected board-certified physicians in the industry, each with many years of experience in their respective specialties.

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FDA-approved Procedures

Rest assured, you are not signing up for treatment with “experimental” methods. CenExel ACMR only uses FDA-approved methods as if you were at any other hospital or clinic. Our research is focused on the medication associated with those methods.

Frequently asked questions

What is a CenExel Center of Excellence?

CenExel Centers of Excellence provide unparalleled medical and scientific support in the design and execution of clinical trials. Their attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. They have conducted thousands of studies, the variety and complexity of which have resulted in a great depth of experience and insight for the principal investigators and research staff in each facility. CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that clients achieve their clinical research goals.

How do clinical trials work?

The study procedures and process will vary depending on the type of clinical trial you participate in. Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.

Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.

How safe are clinical studies?

There are many safeguards in place that all companies must follow when conducting clinical trials.

The Food and Drug Administration (FDA) is the regulatory agency that oversees all clinical research conducted in the United States. It is their responsible to protect the rights and as much as possible, the welfare of subjects participating in clinical trials. They ensure that data collected from clinical trials is of the highest quality and they are the agency that determines whether a new treatment should be sold in the US. Several organizations and individuals are governed by FDA regulations including clinical investigators, sponsors (the companies developing the treatments), Contract Research Organizations (companies that help conduct the studies), and Institutional Review Boards (groups that are responsible for ensuring the safety and welfare of study participants).

Good Clinical Practice (GCP) guidelines are another safeguard implemented to protect the safety of subjects. These guidelines encompass federal regulations and industry-accepted standards that govern clinical trials on humans. These regulations and standards apply to the conduct of the studies, record keeping, informed consent of subjects, collection of scientific data, and submission of information needed for the FDA to determine whether a new treatment should or should not be sold in the US. All companies must follow these guidelines when conducting clinical research.

An Institutional Review Board (IRB) is a committee that is formally tasked by an institution to review, approve, and monitor research involving human subjects. IRBs ensure that the risks to subjects are minimized; that subjects are adequately informed about the trial and the implications it will have on their treatment; that study protocols are modified, when necessary, to ensure safety; that risks are reasonable in relation to the anticipated benefits and the importance of the knowledge to be gained; that subject selection is equitable and that no classes of patients are discriminated against; that informed consent is obtained; that there is a provision for safety monitoring in the research plan; and that here are adequate provisions for the privacy and confidentiality for subjects and the data collected.

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