Insights into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study

The Insights into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS) study is exploring sickle cell disease in adults by looking at many factors, including genomic, microbial, physical and social influences.

Overview

Insights logo

The goal of this study is to learn how these factors influence the onset and development of sickle cell leg ulcers. While leg ulcers are a primary focus of this study, we are investigating the disease as a whole and studying the wide range of complications that sickle cell patients experience.

We plan to enroll 300 participants in the study and are currently recruiting volunteers!

Each study participant will have a clinical visit that will include a medical and family history, physical exam, bloodwork and a survey obtaining data on environmental and psychosocial questions important in health. Some participants will have their skin microbiome tested for bacteria and fungi.

A key component of the study is understanding the role of stress in sickle cell disease. We will measure biomarkers for stress from blood and hair, and collect self-reported experiences with stress. Participants with leg ulcers will receive standardized wound care during the visit.

ClinicalTrials.gov: Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study

Study Brochure

If you would like to participate in the Insights study, please call the team at 301-451-3997 or email us at SCDlegulcerstudy@mail.nih.gov.

Eligibility

Are you living with sickle cell disease (SCD)? Does it impact your life? Are you interested in helping researchers understand how your environment and genome may impact your sickle cell disease? Are you interested in helping researchers understand sickle cell disease leg ulcers? Are you interested in helping researchers identify new treatments to improve the health of others with the disease?

If so, you may want to participate in this study.

We will utilize new sequencing technology and social science approaches to identify microbiome, genomic and environmental contributions to sickle cell disease with a special emphasis on the factors that cause a subset of SCD patients to develop leg ulcers. More broadly, we are seeking to understand how the combinations of factors (i.e., microbiome, genetic modifiers, environmental and social indicators) influence disease progression and leg ulcer formation and health. Your participation may contribute to the development of new treatments and interventions.

Criteria

You have sickle cell disease
You are over the age of 18
You do or do not have a leg ulcer

What you can expect

Skin swabs to test your skin microbiome
Leg ulcer, wound care treatment if needed
Survey questions about your health care experiences, social and physical environment and current quality of life
Blood sample will be collected to study your current health and your genetic variants important in sickle cell disease

Study Location

The study will take place at the National Institutes of Health Clinical Center in Bethesda, Maryland. Compensation will be provided for time and travel.