Why Participate?
If eligible, you will receive study-related care at no cost to you. While you are participating in this study, your study doctor will closely monitor your progress. Your participation may help future patients like you.
About The Study
The purpose of this study is to learn more about the safety and effectiveness of a potential non-surgical treatment option for plantar fibromatosis. This drug is not currently approved for the treatment of plantar fibromatosis but has been approved for other indications.
Participants in the study will receive up to 6 injections into the nodules in the foot with either the study drug or a placebo (does not contain any active drug). Neither you nor your doctor will know if you receive the study drug or placebo.
What To Expect
To see if you are eligible to participate, you will be asked to visit one of our study sites to complete several tests. These tests will include but are not limited to collection of blood, electrocardiogram (ECG), Foot Function Index, and assessment of the nodules (consistency, hardness, and location).
If you are eligible, you will take part in the study treatment period which will last 57 days. Participation includes, but is not limited to, visiting your study doctor, injection treatments, and necessary tests and procedures.
Before you begin the study, the study doctor will meet with you to explain all the details of the clinical trial. They will answer any questions you might have.
What is Plantar Fibromatosis?
Plantar Fibromatosis is a fibrous knot, or nodule, that develops in the arch of the foot. The nodule is embedded in the plantar fascia, which is a band of tissue extending from the heel to the toe on the bottom of the foot. The knot may initially cause little or no pain but can get bigger and become more painful over time. Treatment options can range from steroid injections and physical therapy to surgery.