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

NCT02156102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 405

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    lead NIH

Principal Investigators

  • Laura M Koehly, Ph.D. · National Human Genome Research Institute (NHGRI)

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-16
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • United States
  • Sierra Leone

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156102 on ClinicalTrials.gov