Genetic DiseaseNCT02156102
Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)
An observational study of Genetic Disease and Genomics, run by National Human Genome Research Institute (NHGRI) at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Genetic Disease, Genomics
- How many people
- 405 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 16 Jun 2014to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a descriptive study of individuals living with sickle cell diseases (SCD) with and without leg ulcers (accrual goal 550 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 male or female adult participants with ulcers, currently without leg 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, and/or referrals.
Who may be able to join
- We will enroll up to four-hundred and fifty (N=450) participants in the microbiome sampling cohort. In addition to the 300 SCD leg ulcer microbiome participants, we will recruit up to an additional 200-250 SCD participants that will complete the clinical evaluation, (including blood sample) and survey instruments for a total of up to 550 participants at three sites, NIH (n=200) and MMC (n=100), and Sierra Leone (n=250).
- Of the total participants, we will resample the microbiome of up to 75 individuals from each of the 3 initial sampling groups: SCD with, without and never had SCD leg ulcers. Of those 75 individuals who are sampled longitudinally, those with clinically interesting cases may be sampled at multiple intervals.
- All sampling, surveys, and processing of samples will take place at the NIH Clinical Center the second site, MMC, or in Sierra Leone. All samples will be stored at NIH.
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- All subjects must have a diagnosis of sickle cell disease (HbSS, HgSC, HbSB 0 or HBSB+)
- Be at least 18 years old.
Show all 9Show fewer
- Provide written informed consent.
- For the Qualitative phase: must have a recurrent, active, or single-occurrence presentation of a leg ulcer(s).
- For the resilience study analysis: 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.
Who cannot join
- Any individual 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10467
Sierra Leone1 site
University of Sierra Leone, College of Medicine and Allied Health Services
Freetown
About this study
Official title: Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers
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.
Read more
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.
Read the detailed description
Study 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. The etiology of SCD-associated leg ulcers is unclear, and we hypothesize that predisposition to developing leg ulcers is multifactorial. This multisite 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 microbiome and the psychosocial and environmental factors that may impact this complication.
Objectives:
Primary Objective:
Employ genomic approaches to characterize the skin microbiome in individuals living with SCD with and without leg ulcers.
Secondary Objective:
- 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 ulcers.
- Develop new measure of severity for SCD that integrates clinical outcomes and the quality of life of the participant.
- Develop guidelines for researchers to address the needs of diverse and under-resourced groups in genetic research.
Endpoints:
Primary Endpoint:
To characterize the microbiome of leg ulcers in SCD.
Secondary Endpoints:
- To characterize the phenotypic variation in SCD.
- To identify similarities and differences of the microbial signatures of chronic diabetic foot ulcers and SCD leg ulcers.
- To investigate physical and psychosocial environmental indicators that impact quality of life in individuals living with SCD with and without leg ulcers.
- To determine if an association exists between the microbiome (microbial diversity) of SCD leg ulcers and the quality of life (psychosocial and physical environment) indicators of individuals with SCD leg ulcers.
- To determine if an association exists between the microbiome (microbial diversity) of SCD leg ulcers and clinical phenotype of individuals with SCD leg ulcers.
- To determine how leg ulcers influence one s physical function and one s perceptions of stigma and self-esteem.
- To identify factors that are indicators of both quality of life and clinical severity of the participant.
- To identify specific psychosocial and environmental factors related to resilience in our study population.
- To investigate current practices and policies around the return of secondary findings in genome sequencing studies in under-resourced study participant populations, and to explore ethical and clinical policies for returning secondary findings by examining various practices within the research community.
- To investigate SCD variation in phenotype, microbiome, physical and psychosocial environments in a cohort in Sierra Leone.
- To compare similarities and differences in phenotype, microbiome, physical and psychosocial environments between U.S. and Sierra Leone cohorts.
- Conditions
- Genetic Disease, Genomics
- Keywords
- Genetic Disorders, Health contributors, Multifactorial, African American, African, Natural History
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Microbiome with no active Leg Ulcer | We will recruit and obtain microbiome samples from male or female adult participants without active leg ulcers but do have sickle cell disease. | |
| Non-microbiome participants | We will recruit but not obtain microbiome samples from participants with sickle cell disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The skin microbiome
Employ genomic approaches to characterize the skin microbiome in individuals living with SCD with and without leg ulcers
Measured: Assessment occurs on date of visit.
The factors that impact quality of life
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 ulcers
Measured: Assessment occurs on date of visit.
Sickle Cell disease severity measure
Develop new measure of severity for SCD that integrates clinical outcomes and the quality of life of the participant
Measured: Assessment occurs on date of visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study start16 Jun 2014
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura M Koehly, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156102
- Sponsor's protocol ID
- 140125
- Other IDs
- 14-HG-0125
- Status last verified
- 9 Sep 2026
- First submitted
- 4 Jun 2014
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20872960Umeh 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.
PubMed 29045487Crouch 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 4:10.1002/ajh.25129. doi: 10.1002/ajh.25129. Online ahead of print. No abstract available.
PubMed 29726579Abdallah KE, Cooper KE, Buscetta AJ, Ramirez HC, Neighbors HW, Bonham VL. An Examination of John Henryism in Adults Living with Sickle Cell Disease. J Racial Ethn Health Disparities. 2025 Aug;12(4):2335-2344. doi: 10.1007/s40615-024-02054-5. Epub 2024 Jul 8.
PubMed 38977655Raymond MB, Cooper KE, Parker LS, Bonham VL. Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants. Public Health Genomics. 2021;24(5-6):241-252. doi: 10.1159/000516782. Epub 2021 Jul 6.
PubMed 34229325Desine S, Eskin L, Bonham VL, Koehly LM. Social support networks of adults with sickle cell disease. J Genet Couns. 2021 Oct;30(5):1418-1427. doi: 10.1002/jgc4.1410. Epub 2021 Apr 12.
PubMed 33847032
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers
- ClinicalTrials.gov ID
- NCT02156102
- Acronym / sponsor ID
- 140125
- Conditions
- Genetic Disease, Genomics
- Keywords
- Genetic Disorders, Health contributors, Multifactorial, African American, African, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study 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. The etiology of SCD-associated leg ulcers is unclear, and we hypothesize that predisposition to developing leg ulcers is multifactorial. This multisite 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 microbiome and the psychosocial and environmental factors that may impact this complication.
Objectives:
Primary Objective:
Employ genomic approaches to characterize the skin microbiome in individuals living with SCD with and without leg ulcers.
Secondary Objective:
- 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 ulcers.
- Develop new measure of severity for SCD that integrates clinical outcomes and the quality of life of the participant.
- Develop guidelines for researchers to address the needs of diverse and under-resourced groups in genetic research.
Endpoints:
Primary Endpoint:
To characterize the microbiome of leg ulcers in SCD.
Secondary Endpoints:
- To characterize the phenotypic variation in SCD.
- To identify similarities and differences of the microbial signatures of chronic diabetic foot ulcers and SCD leg ulcers.
- To investigate physical and psychosocial environmental indicators that impact quality of life in individuals living with SCD with and without leg ulcers.
- To determine if an association exists between the microbiome (microbial diversity) of SCD leg ulcers and the quality of life (psychosocial and physical environment) indicators of individuals with SCD leg ulcers.
- To determine if an association exists between the microbiome (microbial diversity) of SCD leg ulcers and clinical phenotype of individuals with SCD leg ulcers.
- To determine how leg ulcers influence one s physical function and one s perceptions of stigma and self-esteem.
- To identify factors that are indicators of both quality of life and clinical severity of the participant.
- To identify specific psychosocial and environmental factors related to resilience in our study population.
- To investigate current practices and policies around the return of secondary findings in genome sequencing studies in under-resourced study participant populations, and to explore ethical and clinical policies for returning secondary findings by examining various practices within the research community.
- To investigate SCD variation in phenotype, microbiome, physical and psychosocial environments in a cohort in Sierra Leone.
- To compare similarities and differences in phenotype, microbiome, physical and psychosocial environments between U.S. and Sierra Leone cohorts.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Microbiome with no active Leg Ulcer | – | –We will recruit and obtain microbiome samples from male or female adult participants without active leg ulcers but do have sickle cell disease. |
| Non-microbiome participants | – | –We will recruit but not obtain microbiome samples from participants with sickle cell disease |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a descriptive study of individuals living with sickle cell diseases (SCD) with and without leg ulcers (accrual goal 550 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 male or female adult participants with ulcers, currently without leg 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, and/or referrals.
Key inclusion criteria (9 listed)
- We will enroll up to four-hundred and fifty (N=450) participants in the microbiome sampling cohort. In addition to the 300 SCD leg ulcer microbiome participants, we will recruit up to an additional 200-250 SCD participants that will complete the clinical evaluation, (including blood sample) and survey instruments for a total of up to 550 participants at three sites, NIH (n=200) and MMC (n=100), and Sierra Leone (n=250).
- Of the total participants, we will resample the microbiome of up to 75 individuals from each of the 3 initial sampling groups: SCD with, without and never had SCD leg ulcers. Of those 75 individuals who are sampled longitudinally, those with clinically interesting cases may be sampled at multiple intervals.
- All sampling, surveys, and processing of samples will take place at the NIH Clinical Center the second site, MMC, or in Sierra Leone. All samples will be stored at NIH.
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- All subjects must have a diagnosis of sickle cell disease (HbSS, HgSC, HbSB 0 or HBSB+)
Key exclusion criteria (5 listed)
- Any individual 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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 ulcers
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 20872960Minniti 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.
- Background: PubMed 29045487Umeh 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.
- Background: PubMed 29726579Crouch 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 4:10.1002/ajh.25129. doi: 10.1002/ajh.25129. Online ahead of print. No abstract available.
- Derived from this study: PubMed 38977655Abdallah KE, Cooper KE, Buscetta AJ, Ramirez HC, Neighbors HW, Bonham VL. An Examination of John Henryism in Adults Living with Sickle Cell Disease. J Racial Ethn Health Disparities. 2025 Aug;12(4):2335-2344. doi: 10.1007/s40615-024-02054-5. Epub 2024 Jul 8.
- Derived from this study: PubMed 34229325Raymond MB, Cooper KE, Parker LS, Bonham VL. Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants. Public Health Genomics. 2021;24(5-6):241-252. doi: 10.1159/000516782. Epub 2021 Jul 6.
- Derived from this study: PubMed 33847032Desine S, Eskin L, Bonham VL, Koehly LM. Social support networks of adults with sickle cell disease. J Genet Couns. 2021 Oct;30(5):1418-1427. doi: 10.1002/jgc4.1410. Epub 2021 Apr 12.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Koehly, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Disease and Genomics, run by National Human Genome Research Institute (NHGRI) at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The skin microbiome (time frame: Assessment occurs on date of visit.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156102, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.