Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)

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

- 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).