Scientists hunt for hidden causes of painful leg ulcers in sickle cell disease
NCT ID NCT02156102
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 12 times
Summary
This completed study looked at why people with sickle cell disease develop chronic leg ulcers. Researchers collected skin swabs, blood samples, and survey data from 405 adults to explore the role of skin bacteria and environmental factors. The goal was to better understand the causes, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify why leg ulcers form in sickle cell disease, pointing toward better prevention or care strategies.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly test any new therapy, and findings may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
405 people
The number who actually took part.
- Started
-
Jun 2014
- Finished
-
Oct 2024
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: 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. * 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. EXCLUSION CRITERIA: 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Genetic disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10467, United States
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
-
University of Sierra Leone, College of Medicine and Allied Health Services
Freetown, Sierra Leone
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sickle cell clues to diabetes risk hidden in DNA
- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Can a simple blood draw map a Baby's genetic risks?
- Gene editing offers hope for a One-Time sickle cell cure
- A gene variant found mostly on one island could reshape breast cancer screening
- Hidden gut inflammation may drive familial mediterranean fever