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Podoconiosis clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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Terminated
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NCT ID: NCT01939431 Terminated - Podoconiosis Clinical Trials

Genetic and Other Aspects of Podoconiosis

Start date: August 20, 2013
Phase:
Study type: Observational

Background: - Podoconiosis is a disease of the lymph vessels in the legs and feet. It is caused by long-term barefoot exposure to irritant soils, such as those in volcanic areas. It causes severe swelling and disfigurement, as well as infection and chronic pain. It mostly affects people who live in tropical Africa, Central and South America, and India. The reasons why some people develop this disease and others do not is not well understood. Researchers want to study people with the disease and healthy volunteers in Ethiopia. They will collect skin and blood samples to study genetic and other aspects of the disease. Objectives: - To collect skin and blood samples to study genetic and other aspects of podoconiosis. Eligibility: - Individuals at least 18 years of age who have podoconiosis (early stage or advanced stage). - Healthy volunteers at least 18 years of age. - Participants will be recruited from a study clinic and hospital in Ethiopia. Design: - Participants will be screened with a physical exam and medical history. - Blood samples will be collected. A skin biopsy will be performed to collect tissue for study. People who have podoconiosis will provide affected and unaffected tissue. Healthy volunteers will provide a single skin biopsy sample. - Treatment will not be provided as part of this study.