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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 : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Brief Summary:

Background:

- 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.

Condition or disease
Genetic Disease Genomics

Detailed Description:

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 multi site 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 mircobiome 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; (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. This will afford participants the chance to expound upon existing questions and will provide us the opportunity to understand the complexity of participants experiences and quality of life


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers
Actual Study Start Date : May 22, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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. The total sample size will be no more than 250.
Microbiome with no active leg ulcer
We will recruit and obtain mircobiome samples from male or female adult participants without active leg ulcers but do not have sickle cell disease. The total sample size will be no more than 250.
non-microbiome participants
We will recruit but not obtain microbiome samples from participants with sickle cell disease



Primary Outcome Measures :
  1. 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 leg ulcers

  2. 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

  3. 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



Information from the National Library of Medicine

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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
Study Population
This is a descriptive study of individuals living with sickle cell diseases (SCD) with and without leg ulcers (accrual goal 300 participants). Leg ulcers are not observed in all individuals with SCD and we are interested in understanding why certain individuals develop leg ulcers. We will seek to include age-matched patients without leg ulcers for the microbiome phase of the study. We will recruit and sample from a toatl of 250 male or female adult participants with ulcers, currently without ulcers, and those with no previous history of leg ulcers. To ensure we recruit an adequate number of participants with and without leg ulcers, we will rely on multiple recruiting methods, which will include posting flyers, social media advertisements.
Criteria
  • 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).

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).


Information from the National Library of Medicine

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


Contacts
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Contact: Vence L Bonham, J.D. (301) 594-3973 bonhamv@nhgri.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
United States, Wisconsin
University of Wisconsin Survey Center Recruiting
Madison, Wisconsin, United States, 53706
Contact: Nathan Jones, Ph.D.    608-890-4727    nrjones@ssc.wisc.edu   
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Vence L Bonham, J.D. National Human Genome Research Institute (NHGRI)

Additional Information:
Publications:
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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT02156102     History of Changes
Other Study ID Numbers: 140125
14-HG-0125
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: March 6, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Genetic Disorders
Health contributors
Multifactorial
African American
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Genetic Diseases, Inborn
Leg Ulcer
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Skin Ulcer
Skin Diseases