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A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
What is ulcerative colitis?
Ulcerative colitis, or UC, is a form of inflammatory bowel disease. Abnormal reactions of the immune system cause inflammation and open sores called ulcers on the inner lining of the large intestine, meaning the colon and the rectum. That leads to diarrhea, blood in the stool, and belly pain. UC doesn't only affect the colon either. It's linked to higher rates of arthritis, and specifically to ankylosing spondylitis and psoriasis, conditions doctors call extraintestinal manifestations of the disease. It most often starts between ages 15 and 30, though it can begin at any age. About 1.25 million Americans have been diagnosed with UC, which makes it the more common form of IBD in adults, slightly ahead of Crohn's disease.
Research in this field has its own shape. Most UC studies check whether a drug worked with a colonoscopy or sigmoidoscopy at set visits, because it is not enough for a person to feel better, a camera has to show the colon lining healing. That is also why UC trials run in two stages, one to see if the drug works fast and a longer one to see if the effect lasts. And there is a gap the field wants to close: UC affects every racial and ethnic group, but Black, Hispanic, and Asian patients are still underrepresented in IBD research, so many studies actively welcome them.
Wondering why diversity in research matters? Here's the full picture.
Can ulcerative colitis be cured?
Not yet. UC is a chronic condition, and the medicines doctors use today are there to calm the inflammation and keep it calm, not to end the disease. But the search for something better is busy. More than 70 companies are working on new UC drug candidates right now, and the ones furthest along are in studies enrolling people.
Is ulcerative colitis genetic?
Genes are part of it, but they are not the whole story. About 1 in 10 people with UC have a family member with inflammatory bowel disease, and close relatives, meaning a parent, a brother or sister, or a child, have about four times the risk. Most people with UC have no family history at all. And UC is not contagious. You cannot catch it from anyone or pass it to anyone, because it does not come from an infection.
Types of trials used for ulcerative colitis
Ulcerative colitis clinical trials can be designed using a variety of different types and methodologies. The chosen trial type by researchers will depend on the trial objectives and other factors for consideration.
Diagnostics trials
With ulcerative colitis typically being hard to diagnose, diagnostics trials are a keen focus for researchers. Diagnostic trials for ulcerative colitis place an emphasis on developing and evaluating new tools, techniques, or criteria for accurately diagnosing and monitoring the disease. These trials may test advanced imaging technologies, biomarkers, or innovative diagnostic methods to improve early detection, assess disease activity, and differentiate ulcerative colitis from other similar conditions, such as Crohn's disease.
Participants in these trials undergo various tests to determine the effectiveness and accuracy of these new diagnostic approaches. The goal is to enhance the precision of diagnosis, allowing for more timely and personalized treatment strategies, ultimately leading to better patient outcomes.
Interventional trials
Interventional trials studying ulcerative colitis are designed to evaluate the safety and efficacy of new treatments or therapies by administering experimental medications, biologics, or other interventions to participants. These trials test various approaches, including novel drugs, combination therapies, or advanced delivery systems, to determine their impact on reducing inflammation, alleviating symptoms, and achieving long-term remission.
Participants are closely monitored for changes in their condition, side effects, and overall response to the treatment. The findings from interventional trials help to establish new standards of care, improve treatment options, and enhance the management of ulcerative colitis.
Observational studies
Researchers may use observational trials for ulcerative colitis to monitor patients over time and gather various data without administering experimental interventions. Depending on the trial objectives, they could study the natural progression of the disease, responses to existing treatments, and factors that influence outcomes. Observational trials help researchers identify patterns in how the disease develops and affects individuals, including the impact of lifestyle, genetics, and environmental factors.
By analyzing the gathered data, observational studies can provide valuable insights into the disease's course, risk factors, and the effectiveness of standard treatments, which can inform future clinical practices and guide the development of new therapeutic approaches.
Who can participate in ulcerative colitis clinical trials?
It depends on the study, and in UC the study title usually tells you a lot before you even open it. Doctors describe UC by how far the inflammation extends and how active it is, and trials recruit on that same activity label. Most drug studies on this page ask for moderately to severely active UC, confirmed by symptoms plus an endoscopy. A smaller group looks for mild to moderate disease instead, and a few enroll children and teens rather than adults. Many studies also ask what you have already tried, since some want people who did not respond to an advanced therapy before and others want people who never took one. Researchers are also trying to reach patients from communities that IBD research has historically missed. Eligibility always varies by study.
How to enroll in an ulcerative colitis clinical trial
Enrolling in a clinical trial studying ulcerative colitis through our platform is a straightforward and user-friendly process. Here's how to get started:
- Identify Your Trial: Use our intuitive search bar or filter options to locate clinical trials specific to requirements. This first step simplifies the process of finding relevant research studies tailored to your needs.
- Select Your Preferred Location: To find trials conveniently located near you, simply input your preferred location into the dedicated filter bar on the left-hand side of the page.
- Explore Study Details: For in-depth information about each study, simply click the “Learn More” button. This will provide you with comprehensive details about the trial, including objectives, procedures, and eligibility criteria.
- Complete the Health Profile: After clicking on the “Get started” button you will be taken to our efficient 5-step application process to provide important health information. This helps us match you with the clinical trial that best fits your needs.
- Submit the Application: After completing the application, send it in. A clinical trial coordinator will review it and contact you regarding the possibility of participation.