TerminatedNot Applicable

Genetic and Other Aspects of Podoconiosis

Stopped: Slow/Insufficient accrual

Ethiopia76 participantsStarted 2013-08-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

In addition to clinical criteria that make patients and controls non-eligible to undergo surgery, we will also exclude individuals with skin infection, skin lesion at the prospective biopsy site, medical contradictions to biopsy, history of adenolymphangitis during the previous 2 weeks, topical steroid treatment during the previous 2 weeks, with biologically related family members that are included in the study, recent infection, use of systemic antibiotics and use of systemic steroids. Attempts will be made to enroll an equal number of men and women. No prisoners, pregnant women or fetuses will be included in this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Natural History

Timeframe: Ongoing

Trial details

NCT IDNCT01939431

SponsorNational Human Genome Research Institute (NHGRI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-12-30

View on ClinicalTrials.gov More Podoconiosis trials