CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 405 enrolled / 405 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02156102
NCT02156102N/ACompletedOn Track (2.8/mo)Completion was 21mo ago

Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers

National Human Genome Research Institute (NHGRI)·observational·Posted Jun 5, 2014·Updated Jun 1, 2026

In Brief

An observational study for Genetic Disease and Genomics. Completed, enrolled 405 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSierra Leone, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 5, 2014
Enrollment StartJun 16, 2014
Primary CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 12.1 years ago

Arms & Interventions

Microbiome with active Leg Ulcerother

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 Ulcerother

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 participantsother

We will recruit but not obtain microbiome samples from participants with sickle cell disease