Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)
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|ClinicalTrials.gov Identifier: NCT02156102|
Recruitment Status : Recruiting
First Posted : June 5, 2014
Last Update Posted : February 13, 2023
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- 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.
- To study social and environmental factors of sickle cell disease and the causes of sickle cell disease leg ulcers.
- People age 18 and older who have sickle cell disease or another red cell disorder, with or without an active leg ulcer.
- 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.
|Condition or disease|
|Genetic Disease Genomics|
Leg ulcers are a serious and debilitating complication of sickle cell disease (SCD). This study will explore microbial, genomic, and environmental (social and physical) factors, that may influence the onset and progression of leg ulcer formation and delayed healing in individuals living with SCD. There is variation in the incidence and duration of SCD leg ulcers.
They are often very painful, resistant to treatment, and recurrent in nature. The etiology of SCD associated leg ulcers is unclear, and we hypothesize that predisposition to developing leg ulcers is multifactorial. This multisite study is an exploratory study of the microbiome and environment of individuals living with sickle cell disease leg ulcers. The study's objective is to identify triggers that may be integral in leg ulcer onset and progression. The central goal of this study is to obtain an improved understanding of the participants clinical phenotype, leg ulcer microbiome and the psychosocial and environmental factors that may impact this complication. To achieve these goals, we will: (1) characterize the leg skin microbiome of SCD participants living with and without leg ulcers within the United States and Sierra Leone; (2) collect and analyze psychosocial and physical environmental data of individuals with SCD without leg ulcers and with leg ulcers; (3) examine the psychosocial impact of leg ulcers on individuals with SCD by conducting a qualitative phase to explore the individual experiences to understand the physical function, stigma, and self-esteem associated with those with active, recurrent, or single-occurrence presentations of leg ulcers; and (4) explore what factors influence psychological resilience, to examine the relationship of psychological resilience to the health outcomes of an adult population living with sickle cell disease in the U.S. and in Sierra Leone. This will provide us the opportunity to understand the complexity of participants' health, health care experiences and quality of life.
|Study Type :||Observational|
|Estimated Enrollment :||550 participants|
|Official Title:||Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers|
|Actual Study Start Date :||June 16, 2014|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Microbiome with active Leg Ulcer
We will recruit and obtain microbiome samples from male or female adult participants with active leg ulcers and sickle cell disease.
Microbiome with no active Leg Ulcer
We will recruit and obtain microbiome samples from male or female adult participants without active leg ulcers but do have sickle cell disease.
We will recruit but not obtain microbiome samples from participants with sickle cell disease
- The skin microbiome [ Time Frame: Assessment occurs on date of visit. ]Employ genomic approaches to characterize the skin microbiome in individuals living with SCD with and without leg ulcers
- The factors that impact quality of life [ Time Frame: Assessment occurs on date of visit. ]Employ social science research measures to identify psychosocial and physical environmental factors that impact quality of life in individuals living with SCD with and without leg ulcers
- Sickle Cell disease severity measure [ Time Frame: Assessment occurs on date of visit. ]Develop new measure of severity for SCD that integrates clinical outcomes and the quality of life of the participant
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156102
|Contact: Hasmin C Ramirez||(301) firstname.lastname@example.org|
|Contact: Vence L Bonham, J.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|University of Sierra Leone, College of Medicine and Allied Health Services||Recruiting|
|Freetown, Sierra Leone|
|Contact: Cheedy Jaja, PhD (803) 777-0472 firstname.lastname@example.org|
|Principal Investigator:||Vence L Bonham, J.D.||National Human Genome Research Institute (NHGRI)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Human Genome Research Institute (NHGRI)|
|Other Study ID Numbers:||
|First Posted:||June 5, 2014 Key Record Dates|
|Last Update Posted:||February 13, 2023|
|Last Verified:||November 10, 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital