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Protocol Details

Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




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


Population Exclusion(s)



Genetic Disorders;
Health contributors;
African American;
Natural History

Recruitment Keyword(s)



Genetic Disease;

Investigational Drug(s)


Investigational Device(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.


- 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.

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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).

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Minniti CP, Eckman J, Sebastiani P, Steinberg MH, Ballas SK. Leg ulcers in sickle cell disease. Am J Hematol. 2010 Oct;85(10):831-3. doi: 10.1002/ajh.21838.

Umeh NI, Ajegba B, Buscetta AJ, Abdallah KE, Minniti CP, Bonham VL. The psychosocial impact of leg ulcers in patients with sickle cell disease: I don't want them to know my little secret. PLoS One. 2017 Oct 18;12(10):e0186270. doi: 10.1371/journal.pone.0186270. eCollection 2017.

Crouch EM, Bonham VL, Abdallah K, Buscetta A, Vinces G, Heo M, Minniti CP. Nutritional supplement profile of adults with sickle cell disease. Am J Hematol. 2018 May 4. doi: 10.1002/ajh.25129. [Epub ahead of print]

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Principal Investigator

Referral Contact

For more information:

Vence L. Bonham, J.D.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 2
Room 4W01
Bethesda, Maryland 20892
(301) 594-3973

Hasmin C. Ramirez
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Building 31
Room B1B54
31 Center Drive
Bethesda, Maryland 20892
(301) 435-6817

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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