This study is currently recruiting participants.
Number
14-HG-0125
Sponsoring Institute
National Human Genome Research Institute (NHGRI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Genetic Disorders; Health contributors; Multifactorial; African American; African; Natural History
Recruitment Keyword(s)
None
Condition(s)
Genetic Disease; Genomics
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Human Genome Research Institute
- People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers. These are wounds that develop on the skin and don t go away. Current treatments do not work very well, so researchers want to learn more about why the ulcers happen. They want to find out which bacteria may cause it, and if external factors play a role.
Objective:
- To study social and environmental factors of sickle cell disease and the causes of sickle cell disease leg ulcers.
Eligibility:
- People age 18 and older who have sickle cell disease or another red cell disorder, with or without an active leg ulcer.
Design:
- Participants will have a medical history and clinical evaluation. They will also have blood drawn.
- Participants will complete questionnaires about their life, health, environment, stress, and other topics.
- Participants may provide a small sample of hair.
- Participants will be asked to collect a small amount of saliva.
- Participants with leg ulcers will have their skin microbiome sampled. The microbiome is all of the microbes (bacteria and and/or fungi) and their genes in and on the body. Researchers will use swabs to collect skin samples. Photographs will be taken of the skin sample area.
- Some participants without leg ulcers also will have their skin microbiome sampled.
- Some participants who have their skin microbiome sampled will return for a second visit. At this visit, their microbiome will be resampled. It will take place more than 30 days after the first visit.
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INCLUSION CRITERIA: Each subject must meet all of the following inclusion criteria during the screening process in order to participate in the study: -- All subjects must have a diagnosis of sickle cell disease (HbSS, HgSC, HbSB 0 or HBSB+) -- Be at least 18 years old. -- Provide written informed consent. --For the Qualitative phase: must have a recurrent, active, or singleoccurrence presentation of a leg ulcer(s). --For the resilience study analysis: this cohort will be determined by the research team based on the results of part I of this analysis. For part I, the inclusion criteria are that the individual must have enrolled and completed the INSIGHTS study. EXCLUSION CRITERIA: Any subject that meets any of the following criteria during baseline evaluation will be excluded from the study: -- Pediatric population (<18 years old) -- Participants for microbiome study (only) who have received oral and/or topical antibiotics or antifungals < 2 weeks prior to enrolling in the study for leg ulcers (for those with leg ulcers only) -- Subjects presenting with clinically diagnosed bacterial infection (i.e. clinical appearance, clinical judgment, fever, redness around ulcer, purulent drainage etc.) at the site of ulceration. (This can only be diagnosed clinically by the research nurse during sampling and is only applicable to those with leg ulcers only).
Each subject must meet all of the following inclusion criteria during the screening process in order to participate in the study:
-- All subjects must have a diagnosis of sickle cell disease (HbSS, HgSC, HbSB 0 or HBSB+)
-- Be at least 18 years old.
-- Provide written informed consent.
--For the Qualitative phase: must have a recurrent, active, or singleoccurrence presentation of a leg ulcer(s).
--For the resilience study analysis: this cohort will be determined by the research team based on the results of part I of this analysis. For part I, the inclusion criteria are that the individual must have enrolled and completed the INSIGHTS study.
EXCLUSION CRITERIA:
Any subject that meets any of the following criteria during baseline evaluation will be excluded from the study:
-- Pediatric population (<18 years old)
-- Participants for microbiome study (only) who have received oral and/or topical antibiotics or antifungals < 2 weeks prior to enrolling in the study for leg ulcers (for those with leg ulcers only)
-- Subjects presenting with clinically diagnosed bacterial infection (i.e. clinical appearance, clinical judgment, fever, redness around ulcer, purulent drainage etc.) at the site of ulceration. (This can only be diagnosed clinically by the research nurse during sampling
and is only applicable to those with leg ulcers only).
Principal Investigator
Referral Contact
For more information: