Summary:
If it is difficult to wear certain shoes due to pain or discomfort near your big toe, you may have a bunion.
What Are Bunions?
A bunion is a deformity of the metatarsophalangeal (MTP) joint at the base of the big toe. A bunion develops when the first metatarsal bone of the foot turns outward and the big toe points inward (toward the other toes), causing the joint to jut out.
A bunion is most likely to develop when susceptible feet are repeatedly squeezed into narrow, pointed-toe footwear. The big toe pushes against the other toes, sometimes diving over or under them. As a result, the MTP joint at the base of the big toe juts or angles out from the foot.
What Causes a Bunion?
Shoes with narrow toes can trigger a bunion. However, bunions also run in families, because foot shape and structure are hereditary, and some foot 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 worsen 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. Bunions are also associated with arthritis, which damages the cartilage within the joint.
People in occupations that involve a lot of standing and walking are susceptible to bunions.
Why Treat Bunions?
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 also 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, you may also develop discomfort in the ball of the foot, interfering with daily routines and activities.
As the misshapen joint becomes more uncomfortable and harder to fit into shoes, exercise and other activities, even walking, may become difficult.
If you have a bunion, you may be eligible to participate in a medical research study to evaluate an investigational pain medication containing FDA-approved ingredients as a treatment for pain following bunion removal.
What is the CLCT-003 study?
This investigational research study is being done with people who want to have surgery to remove a bunion on the foot and who experience pain after the surgery. The purpose of this study is to see if taking the investigational drug CL-108 is safe and works in relieving pain after bunionectomy surgery. "Investigational" means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA) for this indication. This study will help determine how safe CL-108 is and how well your body reacts to CL-108 as compared to the commercial formulation of Norco® and placebo (sugar pill).
What is the investigational medication?
For this study, capsules will be provided containing CL-108, Norco®, or placebo.
CL-108 contains three different drugs, each of which has been approved separately by the Food and Drug Administration (FDA): promethazine + hydrocodone + acetaminophen. Promethazine has been approved by the FDA for the prevention and treatment of nausea and vomiting. Hydrocodone and acetaminophen have been approved by the FDA for the treatment of pain.These three drugs are combined as a single pill, CL-108, which has not been approved by the FDA.
Norco® contains two of these approved drugs: hydrocodone + acetaminophen. These two drugs are combined as a single pill, Norco®, which has been approved by the FDA for the treatment of pain.
Who can participate in the study?
You may be able to participate in this study if you:
- Are at least18 years old
- Have at least one qualifying bunion that requires surgical removal
- Be available for a three-night stay in the clinic
Qualified participants will receive the following at no cost:
- Bunion removal by a board-certified podiatrist
- Study-related physical exams
- Investigational study medication, Norco®, or placebo
- Financial compensation for time and travel related to the study